Endoscopic Treatment of Intestinal Fistulas and Perforations
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|ClinicalTrials.gov Identifier: NCT01303653|
Recruitment Status : Unknown
Verified July 2010 by The Oregon Clinic.
Recruitment status was: Recruiting
First Posted : February 25, 2011
Last Update Posted : February 28, 2011
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Fistula Gastrointestinal Perforation||Procedure: endoscopic closure of gastrointestinal fistulas and perforations||Phase 1|
Novel endoscopic devices have the potential to overcome the need for invasive surgery for the treatment of gastrointestinal fistulas or perforations.
Instead of a large abdominal incision or multiple incisions with the related postoperative morbidity endoscopic techniques will be used used which require no postoperative limitation of activities. Using novel tissue closure devices, such as a Tissue Apposition System or an endoscopic suturing system, we will evaluate the potential benefit, risks and impact on the patient's quality of life of this modified surgical technique in patients having either chronic gastrointestinal fistulas or acute perforations.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endoscopic Treatment of Intestinal Fistulas and Perforations|
|Study Start Date :||October 2010|
|Estimated Primary Completion Date :||October 2010|
Procedure: endoscopic closure of gastrointestinal fistulas and perforations
- Either the Tissue Apposition System (Ethicon Endosurgery)
- or the Overstitch (Apollo Endosurgery)
- will be used within this study for tissue closure
- Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 6 months ]elective endoscopy to evaluate tissue closure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01303653
|Contact: Lee L Swanstrom, MD||503 281 email@example.com|
|United States, Oregon|
|Good Samaritan Hospital, Legacy Health System||Recruiting|
|Portland, Oregon, United States, 97210|
|Contact: Lee L Swanstrom, MD 503-281-0561 firstname.lastname@example.org|
|Sub-Investigator: Erwin Rieder, MD|
|Sub-Investigator: Angi Gill, RN|