Endoscopic Treatment of Intestinal Fistulas and Perforations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
The Oregon Clinic

February 24, 2011
February 25, 2011
February 28, 2011
October 2010
October 2010   (Final data collection date for primary outcome measure)
Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 6 months ]
elective endoscopy to evaluate tissue closure
Same as current
Complete list of historical versions of study NCT01303653 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Endoscopic Treatment of Intestinal Fistulas and Perforations
Endoscopic Treatment of Intestinal Fistulas and Perforations
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.

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.

Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Gastrointestinal Fistula
  • Gastrointestinal Perforation
Procedure: endoscopic closure of gastrointestinal fistulas and perforations
novel endoscopic tissue closure devices will be used for endoscopic closure of gastrointestinal fistulas or perforations
Other Names:
  • Either the Tissue Apposition System (Ethicon Endosurgery)
  • or the Overstitch (Apollo Endosurgery)
  • will be used within this study for tissue closure
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
Not Provided
October 2010   (Final data collection date for primary outcome measure)

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
  • BMI ≥ 40
  • Presence of esophageal stricture
  • Altered gastric anatomy
  • Intraabdominal abscess or severe inflammation
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
LEG 1280
Not Provided
Not Provided
Lee L. Swanstrom, MD, The Oregon Clinic
The Oregon Clinic
Not Provided
Not Provided
The Oregon Clinic
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP