Closure of Anastomotic Leaks in the Stomach and Esophagus by Endoscopic Suturing

NCT ID: NCT01139424

Last Updated: 2010-06-08

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

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-06-30

Brief Summary

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Patients with suspected leakage at the specified surgical anastomoses undergo an immediate diagnostic endoscopy as part of current clinical routine. Consenting patients meeting the inclusion criteria will undergo closure of the defect by endoscopic suturing in addition to standard surgical care.

Detailed Description

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Conditions

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Postoperative Anastomosis, Surgical

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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open label treatment arm

endoscopic suturing

Group Type EXPERIMENTAL

endoscopic suturing

Intervention Type DEVICE

endoscopic suturing of the anastomotic leak

Interventions

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endoscopic suturing

endoscopic suturing of the anastomotic leak

Intervention Type DEVICE

Other Intervention Names

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Using the Ethicon Endosurgery InScope tissue apposition system (TAS). FDA regulation number 21 CFR 876.1500, CE#: CE0123 (G2S 09 12 57666 029)

Eligibility Criteria

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Inclusion Criteria

* leakage at anastomosis within 2 weeks after upper gastrointestinal (GI) resection

Exclusion Criteria

* tubular ischemia of the upper GI tract
* inability to provide informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ethicon Endo-Surgery

INDUSTRY

Sponsor Role collaborator

University Hospital Schleswig-Holstein

OTHER

Sponsor Role lead

Responsible Party

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UKSH

Principal Investigators

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Annette Fritscher-Ravens, MD

Role: PRINCIPAL_INVESTIGATOR

UKSH

Locations

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UKSH

Kiel, Schleswig-Holstein, Germany

Site Status

Countries

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Germany

Central Contacts

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Annette Fritscher-Ravens, MD

Role: CONTACT

0049-431-597-2133

Facility Contacts

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Annette Fritscher-Ravens, MD

Role: primary

0049-431-597-2133

Gudrun Gebhard

Role: backup

0049-431-597-1464

Other Identifiers

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UKSH1

Identifier Type: OTHER

Identifier Source: secondary_id

1-Fritscher-Ravens

Identifier Type: -

Identifier Source: org_study_id

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