Clinical Trial: Endoscopic Treatment of Intestinal Fistulas and Perforations

Study Status: Enrolling by invitation
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Closure of Fistulas and Perforations Endoscopically to Avoid Laparoscopic or Open Surgery

Brief Summary: Gastrointestinal leaks or perforations are currently treated through either open or laparoscopic surgical procedures. The purpose of this research is to determine whether new endoscopic tools are safe and effective in the treatment of such conditions and can overcome the need of invasive surgical procedures.

Detailed Summary:

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.

Sponsor: The Oregon Clinic

Current Primary Outcome: Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome: Same as current

Information By: The Oregon Clinic

Dates:
Date Received: February 2, 2009
Date Started: February 2009
Date Completion:
Last Updated: February 25, 2011
Last Verified: July 2010