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The neoClose Abdominal Closure vs Carter-Thomason Trial

NCT02589171 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2019-08-28

Study results available
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Summary

The purpose of this study is to compare the neoClose abdominal closure to the standard Carter-Thomason closure in a bariatric surgery gastric bypass population.

Conditions

  • Surgical Port Site Hernia

Interventions

DEVICE

Neo Close Abdominal Closure

Neo Close Abdominal Closure

DEVICE

Carter Thomason Device

Carter Thomason Device

Sponsors & Collaborators

  • NeoSurgical Limited

    collaborator INDUSTRY

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Shinil Shah, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-12
Primary Completion
2018-04-25
Completion
2018-04-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02589171 on ClinicalTrials.gov