Endoscopic Treatment of Intestinal Fistulas and Perforations

NCT ID: NCT01303653

Last Updated: 2011-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Brief Summary

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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

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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

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Gastrointestinal Fistula Gastrointestinal Perforation

Keywords

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endoscopic tissue closure, gastro-gastric fistulas, gastrointestinal perforations

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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endoscopic closure of gastrointestinal fistulas and perforations

novel endoscopic tissue closure devices will be used for endoscopic closure of gastrointestinal fistulas or perforations

Intervention Type PROCEDURE

Other Intervention Names

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Either the Tissue Apposition System (Ethicon Endosurgery) or the Overstitch (Apollo Endosurgery) will be used within this study for tissue closure

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Oregon Clinic

OTHER

Sponsor Role lead

Responsible Party

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The Oregon Clinic

Locations

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Good Samaritan Hospital, Legacy Health System

Portland, Oregon, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lee L Swanstrom, MD

Role: CONTACT

Phone: 503 281 0561

Email: [email protected]

Facility Contacts

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Lee L Swanstrom, MD

Role: primary

Other Identifiers

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LEG 1280

Identifier Type: -

Identifier Source: org_study_id