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Endoscopic Treatment of Intestinal Fistulas and Perforations

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by The Oregon Clinic.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Oregon Clinic
ClinicalTrials.gov Identifier:
NCT01303653
First received: February 24, 2011
Last updated: February 25, 2011
Last verified: July 2010

February 24, 2011
February 25, 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 ] [ Designated as safety issue: Yes ]
elective endoscopy to evaluate tissue closure
Same as current
Complete list of historical versions of study NCT01303653 on ClinicalTrials.gov Archive Site
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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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
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
Both
18 Years to 85 Years
No
Contact: Lee L Swanstrom, MD 503 281 0561 lswanstrom@aol.com
United States
 
NCT01303653
LEG 1280
Yes
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