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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
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
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