Synthetic Mesh Explant Study

NCT ID: NCT01880021

Last Updated: 2016-09-23

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

111 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2016-09-30

Brief Summary

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The purpose of this study is to determine whether synthetic hernia mesh materials undergo physical and/or chemical changes while in the body.

Detailed Description

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Conditions

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Polypropylene Polytetrafluoroethylene Histology Materials Testing Herniorrhaphy Humans

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 yrs
* Previous placement of hernia mesh material
* Current need for excision of previous mesh placement or Current need for intra-abdominal surgical procedure

Exclusion Criteria

* Age \< 18 yrs
* No retained mesh prosthetic.
* Non surgical candidate
* Prisoner
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Brunt, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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2010-12735

Identifier Type: -

Identifier Source: org_study_id

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