Endoscopic Treatment of Intestinal Fistulas and Perforations
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- The Oregon Clinic
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- Number of participants with adverse events as a measure of safety and tolerability
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Gastrointestinal fistula and perforation
- •Ability to undergo general anesthesia
- •Ability to give informed consent
Exclusion Criteria
- •Contraindicated for esophagogastroduodenoscopy (EGD)
- •Contraindicated for colonoscopy
- •Presence of esophageal stricture
- •Altered gastric anatomy
- •Intraabdominal abscess or severe inflammation
Outcomes
Primary Outcomes
Number of participants with adverse events as a measure of safety and tolerability
Time Frame: 6 months
elective endoscopy to evaluate tissue closure
Secondary Outcomes
No secondary outcomes reported