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Stapler Post-market Observational Study

NCT ID: NCT02922205

Last Updated: 2020-11-06

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

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-06

Study Completion Date

2020-09-16

Brief Summary

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The purpose of this observational study is to evaluate the safety and performance of the Endoscopic Linear Cutter Stapler and reloads from Fengh Medical used in laparoscopic Roux-en-Y gastric bypass surgery to create anastomoses. The goal of the study will be achieved by assessing the device performance and reporting of peri- and postoperative complications in a prospectively maintained database.

Detailed Description

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Conditions

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Observational

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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RYGB surgery

Obese patients eligible for laparoscopic Roux-en-Y gastric bypass (RYGB) surgery.

Endoscopic Linear Cutter Stapler and reloads

Intervention Type DEVICE

Endoscopic Linear Cutter Stapler and reloads

Interventions

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Endoscopic Linear Cutter Stapler and reloads

Endoscopic Linear Cutter Stapler and reloads

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age at study entry is at least 18 years.
* Patient must sign and date the informed consent form prior to the index-procedure.
* Patient has a BMI ≥ 35 kg/m with one or more related co-morbidity.
* Patient has a BMI ≥ 40 kg/m.

Exclusion Criteria

* Patient is pregnant.
* History of bariatric surgery.
* Patient is known to be, or suspected of being unable to comply with the study protocol or proposed follow-up visits.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duomed

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hans Verhelst, Dr.

Role: PRINCIPAL_INVESTIGATOR

ZOL, Genk

Locations

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Ziekenhuis Oost-Limburg

Genk, Limburg, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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ST-01

Identifier Type: -

Identifier Source: org_study_id