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

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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Fistula Gastrointestinal Perforation Procedure: endoscopic closure of gastrointestinal fistulas and perforations Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic Treatment of Intestinal Fistulas and Perforations
Study Start Date : October 2010
Estimated Primary Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy Fistulas
U.S. FDA Resources

Intervention Details:
    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

Primary Outcome Measures :
  1. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 6 months ]
    elective endoscopy to evaluate tissue closure

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   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
  • BMI ≥ 40
  • Presence of esophageal stricture
  • Altered gastric anatomy
  • Intraabdominal abscess or severe inflammation

Information from the National Library of Medicine

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 identifier (NCT number): NCT01303653

Contact: Lee L Swanstrom, MD 503 281 0561

United States, Oregon
Good Samaritan Hospital, Legacy Health System Recruiting
Portland, Oregon, United States, 97210
Contact: Lee L Swanstrom, MD    503-281-0561   
Sub-Investigator: Erwin Rieder, MD         
Sub-Investigator: Angi Gill, RN         
Sponsors and Collaborators
The Oregon Clinic

Responsible Party: Lee L. Swanstrom, MD, The Oregon Clinic Identifier: NCT01303653     History of Changes
Other Study ID Numbers: LEG 1280
First Posted: February 25, 2011    Key Record Dates
Last Update Posted: February 28, 2011
Last Verified: July 2010

Keywords provided by The Oregon Clinic:
endoscopic tissue closure,
gastro-gastric fistulas,
gastrointestinal perforations

Additional relevant MeSH terms:
Intestinal Fistula
Digestive System Fistula
Pathological Conditions, Anatomical
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases