NCT01303653

Endoscopic Treatment of Intestinal Fistulas and Perforations

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: The Oregon Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Gastrointestinal Fistula
• Gastrointestinal Perforation

Interventions

Type	Name	Description
PROCEDURE	endoscopic closure of gastrointestinal fistulas and perforations	novel endoscopic tissue closure devices will be used for endoscopic closure of gastrointestinal fistulas or perforations

Timeline

• Start date: 2010-10-01
• Primary completion: 2010-10-01
• First posted: 2011-02-25
• Last updated: 2011-02-28

Locations

1 site across 1 country: United States