NCT01880021

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 18, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 23, 2016

Status Verified

September 1, 2016

Enrollment Period

8.5 years

First QC Date

May 31, 2013

Last Update Submit

September 21, 2016

Conditions

HerniorrhaphyHumansPolypropylenePolytetrafluoroethyleneHistologyMaterials Testing

Outcome Measures

Primary Outcomes (1)

  • Fibrosis level of explanted mesh

    Each specimen will be graded and given fibrosis score of 0 - 4 to establish the degree of inflammation/foreign body reaction that occurred while mesh was in vivo.

    Within 2 weeks

Secondary Outcomes (6)

  • Tensile strength of explanted mesh

    Within 2 weeks

  • Collagen protein levels of explanted mesh.

    Within 2 weeks

  • Number of subjects with history of radiation to abdomen/pelvis

    Within 2 weeks

  • Number of subjects with history of chemotherapy

    Within 2 weeks

  • Number of subjects with corticosteroid/immunosuppression therapy

    Within 2 weeks

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects will be recruited from study investigators' patient population.

You may qualify if:

  • 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

You may not qualify if:

  • Age \< 18 yrs
  • No retained mesh prosthetic.
  • Non surgical candidate
  • Prisoner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Study Officials

  • Michael Brunt, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2013

First Posted

June 18, 2013

Study Start

March 1, 2008

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 23, 2016

Record last verified: 2016-09

Locations

US(1)