SprayShield EU Post Market Study Terminated

Sorry everyone...

SprayShield EU Post Market Study

This study has been terminated.

http://clinicaltrials.gov/ct2/show/NCT01002287



First Received on October 26, 2009. Last Updated on May 4, 2010 History of Changes



Sponsor: Confluent Surgical



Information provided by: Confluent Surgical



ClinicalTrials.gov Identifier: NCT01002287



Purpose



This will be a prospective, multi-center, randomized, single blind study to collect and evaluate post-market clinical data on the SprayShield Adhesion Barrier System as an adjuvant to good surgical technique for the reduction of postoperative adhesion formation following major open abdominal surgery.




Condition Intervention Phase



Ulcerative Colitis



Familial Polyposis



Device: SprayShield Adhesion Barrier System



Procedure: Good Surgical Technique Alone



Phase IV





Study Type: Interventional



Study Design: Allocation: Randomized



Intervention Model: Parallel Assignment



Masking: Single Blind (Subject)



Primary Purpose: Prevention



Official Title: An Evaluation of the SprayShield Adhesion Barrier System in Reducing Post-Operative Adhesion Formation Following Major Open Abdominal Surgery




Resource links provided by NLM:





Genetics Home Reference related topics: Crohn disease familial adenomatous polyposis Help Me Understand Genetics



MedlinePlus related topics: Adhesions Ulcerative Colitis



U.S. FDA Resources




Further study details as provided by Confluent Surgical:




Primary Outcome Measures:



•To evaluate the incidence of adhesions, defined as the proportion of subjects presenting at the follow-up surgery (10-12 weeks) with one or more adhesions to the midline incision, regardless of extent and/or severity. [ Time Frame: 10-12 Weeks post Initial Surgery for J-Pouch ] [ Designated as safety issue: No ]





Estimated Enrollment: 30



Study Start Date: October 2009



Estimated Study Completion Date: May 2011



Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)



Arms Assigned Interventions



SprayShield Adhesion Barrier: Experimental



SprayShield Adhesion Barrier + Good Surgical Technique



Intervention: Device: SprayShield Adhesion Barrier System Device: SprayShield Adhesion Barrier System



Adhesion Barrier Device Plus Good Surgical Technique



Control: No Intervention



Good Surgical Technique Alone



Intervention: Procedure: Good Surgical Technique Alone Procedure: Good Surgical Technique Alone



Good Surgical Technique Alone



Eligibility

Ages Eligible for Study: 18 Years and older



Genders Eligible for Study: Both



Accepts Healthy Volunteers: No




Criteria



Inclusion Criteria:




•Diagnosis of ulcerative colitis or familial polyposis and require two-stage surgery for treatment of either of these disorders will be eligible



Contacts and Locations




Please refer to this study by its ClinicalTrials.gov identifier: NCT01002287




Locations



United States, Massachusetts



Confluent Surgical



Waltham, Massachusetts, United States, 02451



Sponsors and Collaborators



Confluent Surgical



More Information




No publications provided




Responsible Party: Confluent Surgical ( Jennifer Doyle/Director, Clinical Affairs )



ClinicalTrials.gov Identifier: NCT01002287 History of Changes



Other Study ID Numbers: ABD-08-001



Study First Received: October 26, 2009



Last Updated: May 4, 2010



Health Authority: Czech Republic: Ethics Committee; Poland: Ministry of Health







Additional relevant MeSH terms:



Colitis



Colitis, Ulcerative



Adenomatous Polyposis Coli



Ulcer



Gastroenteritis



Gastrointestinal Diseases



Digestive System Diseases



Colonic Diseases



Intestinal Diseases



Inflammatory Bowel Diseases



Adenomatous Polyps



Adenoma



Neoplasms, Glandular and Epithelial



Neoplasms by Histologic Type



Neoplasms



Colorectal Neoplasms



Intestinal Neoplasms



Gastrointestinal Neoplasms



Digestive System Neoplasms



Neoplasms by Site



Colonic Neoplasms



Neoplastic Syndromes, Hereditary



Intestinal Polyposis



Genetic Diseases, Inborn



Pathologic Processes




ClinicalTrials.gov processed this record on May 12, 2011

Pity

Surgical gel gets blame for pain

By RUTH HILL - The Dominion Post


NATALIE SLADE/Dominion Post
SCARRED: Carla Gardiner had to have a four-hour operation to remove the scar tissue caused by anti-scarring gel during her initial surgery
Related Links'Scarring more painful than original illness'


A surgical spray gel that may have left hundreds of New Zealand women with painful internal scarring and fertility problems has been modified but doctors have not been told why.
Wellington gynaecologist Hanifa Koya, who first raised concerns about Confluent SprayGel in 2005, accuses the manufacturer of evading its responsibility toward "millions of women" worldwide who have been potentially injured by the gel.
The blue gel renamed SprayShield was supposed to prevent scarring during gynaecological surgery, but left some women with their reproductive organs "super-glued" together.
Up to 1200 New Zealand women were treated with the gel between 2004 and 2008.
Mrs Koya has learned that Covidien, which manufactures and distributes the gel, has replaced the suspect dye, methylene blue, with a vegetable dye. "The fact they withdrew it voluntarily suggests they know there was something wrong with it."
She began using the gel in October 2002, but stopped in April 2006 after her rate of repeat keyhole laparoscopies went from under 2 per cent to 10 per cent. Since switching to an alternative product, she has not repeated any laparoscopies, but patients were still returning from four years ago with "sheets of scarring".
She complained to American manufacturer Confluent Surgical and wrote repeatedly to MedSafe the Government's drug safety agency and professional bodies asking for action, but says she was stonewalled.
Medsafe investigated but accepted the manufacturers' assurances that the product was safe and that clinical trials were continuing.
"[But] methylene blue has never been tested on humans and the gel has never been approved for use in the United States," Mrs Koya said.
At the World Congress on Endometriosis in Melbourne last year, Mrs Koya was appalled to meet other specialists who had stopped using the gel because of complications.
ACC has not accepted any claims by victims for treatment injuries. Most of her patients' repeat operations which cost between $6000 and $12,000 have been covered by insurance, and she has waived her own fee for those with partial cover.
"That's a huge cost to the health system, it leads to increased insurance premiums and makes it harder for people to have their claims accepted. Ultimately it's patients who pay the price."
Health Minister Tony Ryall declined to be interviewed, referring comment to Medsafe.
Medsafe group manager Stewart Jessamine said because the gel was classified as a medical device under the Medicines Act rather than a drug, the legislation did not allow Medsafe to assess its safety or efficacy before it entered the market.

"However ... it has been assessed to very high standards by medical device regulatory authorities in Europe and Australia."
Some studies had showed increased rates of complications, including those described by Mrs Koya, he said. "However, there was no evidence that the rate of adverse effects was significantly different from that expected historically."
TIMELINE
2001: American-made Confluent SprayGel approved for use in Europe and subsequently Australia and New Zealand but not the United States.
OCTOBER 2002: Wellington gynaecologist Hanifa Koya begins using the gel.
2005: Mrs Koya first notices patients coming for repeat surgery and contacts the company, which tells her the product is being monitored in clinical trials.
APRIL 2006: Mrs Koya stops using the gel because of ongoing concerns. She alerts the College of Obstetricians and Gynaecologists and the Centre for Adverse Reaction Monitoring. Both refer her to Medsafe, the Government's drug-safety body.
FEBRUARY 2007: Mrs Koya complains to Medsafe.
NOVEMBER 2007: After reviewing international literature, Medsafe finds some reports of complications similar to those described by Mrs Koya. It asks the company include "additional precautions" on packaging but says the product is still safe.
DECEMBER 2007: Mrs Koya writes to the college again with her concerns.
JANUARY 2008: The college says Medsafe appears to have investigated the issue thoroughly.
FEBRUARY 2008: An affected patient talks to The Dominion Post and Mrs Koya speaks publicly about her concerns.
APRIL 2008: Mrs Koya writes to Medical Assurance Committee of the college.
JUNE 2008: Pharmaceutical company Covidien Tyco takes over distributing the gel in New Zealand from Intermed Medical.
AUGUST 2008: Mrs Koya writes to the health and disability commissioner, but is told the matter is outside the commission's jurisdiction.
OCTOBER 2008: Covidien relaunches the product as SprayShield Adhesion Barrier, which uses a vegetable dye instead of chemical dye methylene blue. The gel is available in Europe, the Middle East, South Africa, Australia and New Zealand but still not approved for use in the US.
http://www.stuff.co.nz/national/health/2480461/Scarring-more-painful-than-original-illness

Adhesion Barrier return on investment

INVESTORS BEWARE!

As IHRT contemplates the desperation of consumers to have adhesion barriers provided in their surgeries and industries willingness to provide them, we are disheartened.
Patients aware of adhesion barriers or indeed adhesions are a slim minority.
Adhesion Barrier Market to Skyrocket to Over $550 Million by 2013PR Newswire (press release), NY - Feb 2, 20092 /PRNewswire/ -- According to Millennium Research Group's (MRG's) US Markets for Surgical Hemostats, Internal Tissue Sealants, and Adhesion Barriers 2009 ...
As we reflect on this headline, one wonders where this number comes from?
IHRT then looks at the source of this press release.
IRONICALLY, Millennium Research Group is based in Waltham, MA, home of Confluent SprayGel and SprayShield !
If an effective adhesion barrier were found and put into use….the number would be enormous!
Here is an example of a guess on what that number might truly be.
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Cesarean Fact Sheet - Childbirth.org
Some facts about cesarean sections from Childbirth.org. ... The latest statistics indicate that 967000 cesareans were performed in the US in 1989. ...www.childbirth.org/section/CSFact.html - 16k - Cached - Similar pages
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Lets say each of these c-sections had and adhesion barrier applied at the cost of $200.00 per procedure. We feel that this would be a very conservative estimate. The cost would be $193,400,000 for just one procedure in which the number of c-section has increased dramatically since this statistic was reported…
Take the history of Spraygel to it’s current incarnation as SprayShield TM.
All IHRT can think to say is, “return on investment”.
Here is an example to see.
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Tuesday, October 28, 2008
Falling apart over Omrix
When I added Omrix Biopharmaceuticals Ltd. (Nasdaq:OMRI) to my portfolio, tracked by "Globes", I noted that it was a profitable biotechnological company in a most interesting niche - biosurgical sealants for the prevention of hemostasis in surgery - and that it was not an all or nothing company, like Pharmos Corp. (Nasdaq: PARSD), for example, where one failed trial can wipe almost an entire investment.
_____________
The founder of Confluent Surgical knew his product would not pass FDA standards so the product was taken out of clinical trials….
Somehow, with fraudulent information SprayGel got it’s CE mark and was used throughout the world as an anti-adhesion barrier. Those in the United States remained safe.
IHRT was founded by the victims of ongoing study of Spraygel until we realized we were being experimented on and paying for the pleasure. In of all places Germany!
The gig was up and Confluent was sold to Tyco which was then sold to Covidien.
As IHRT continues to watch Covidiens stocks fall we become more concerned about them seeking a quick return on their investment!
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Top of Form
COV (Common Stock)
Exchange
NYSE(US Dollar)
Price
$34.46
Change (%)
0.69 (1.96%)
Volume
1,019,293
As of 02/26/09 11:23 a.m. ETMinimum 20 minute delay
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http://investor.covidien.com/preview/phoenix.zhtml?c=207592&p=irol-alerts
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It looks like Covidien may have learned to save money by moving it all offshore just as Confluent did.
Is it the old lets see if it works ON THEM and then go to the FDA?
The same scenario is happening again with of all people, Kruschinski and Mettler. In of all places Germany!
http://www.or-live.com/covidien/2457/Pre-clinical%20Data.pdf
Kruschinski D, Homburg S, D’Souza F, Campbell P, Reich H.
Adhesiolysis in severe and reccurent cases of adhesions related
disorder (ARD) - a novel approach utilizing lift (gasless)
laparoscopy and SprayGel™ adhesion barrier. Surg Technol Int.
2006;15:131-9.

Mettler L, Audebert A, Lehmann-Willenbrock E, Schive-Peterhansl
K, Jacobs VR. A randomized, prospective, controlled,
multicenter clinical trial of a sprayable, site-specific adhesion
barrier system in patients undergoing
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Somehow the bogus science in the above studies are being used once again to tout a product and way after the fact are we learning how the bogus studies of SprayGel made thing worse for us for all of us. Victims of this fraud would tell you there are things worse than death....

It is IHRT’s opinion that until there are actually surgeons learned enough to perform an adhesiolysis that needs no barrier, these products are just a panacea…

Skill is what’s needed and compensation for the time it takes to perform a successful adhesiolyis.
Until then we fell everyone’s just kidding themselves and no product can compensate for, quick or ultra conservative surgery.
So think hard and do your research, be careful of patients who claim this is the best or only way.
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...and then you have Karen Steward!!!! Beware!
How many doctors (surgeons) encourage those who are sick to contact his former patients? No doubt, Dr. Kruschinski has raised the bar of excellence when it comes to "treating" a patient. See: Patient List

Thanks Dr. Kruschinski. Our daughter has regained her life due to your brilliance, commitment and compassion for those who suffer from this dread disorder.
http://www.adhesionpain.net/2008/09/five-yearsthank.html

This is what IHRT calls “Harvesting” a dreadful practice that can lead a person to an unwanted intervention.
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Remember that these biomedical companies and surgeons are expecting a return on their investments and patients are a dime a dozen. We must remember always “people are willing to profit from others pain”. Our capitulation to the adhesion barrier craze just seems to make us “a return on investment”