SprayShield EU Post Market Study Terminated

Um Kru....this is more bad news for you but another reason for people not to seek you out.
Spay Gel was halted in clinical trials too remember....but that didn't stop you from blasting in excessive amounts on unsuspecting patients....then oops an appendix blow on the plane while leaving you...couple of gallbladders.....a dangerous supermarket. Somehow folks just kept on having their adhesions recur....like they always have!

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