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NCT02129140 · ClinicalTrials.gov registry record

Observational Study to Evaluate Ventral Incisional Hernia Repair Using a Biologic Mesh (Cook Biodesign)

A clinical trial, sponsored by Icahn School of Medicine at Mount Sinai.

Completed
Registry status
30
Enrollment target

NCT02129140: Completed study, sponsored by Icahn School of Medicine at Mount Sinai.

NCT02129140 is a clinical trial that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02129140 has completed, sponsored by Icahn School of Medicine at Mount Sinai.

COMPLETED
Registry status
30 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the efficacy of the Cook Biodesign mesh for the repair of complex ventral incisional hernias. Using materials to reinforce tissue defects is indicated as standard of care for this type of surgery. The Cook Biodesign mesh is currently FDA-approved for implantation to reinforce soft tissues where weakness exists, but the investigators would like to collect additional follow-up information to continue to assess the durability of the repair after placement of the hernia mesh. This follow-up would include the collection of information about complications such as infections and seromas (collections of fluid around the surgery site), as well as hernia recurrence and quality of life questionnaires. Patients who qualify to take part in this study have been diagnosed with a ventral incisional hernia and will have been scheduled for a surgical hernia repair. This surgery will be an "open" surgical procedure and reinforcing your tissue with material is indicated for this type of hernia repair.

Primary Outcome

Assessment of efficacy of the device and repair

Interventions

  • DEVICE Hernia graft/mesh

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2014-04
Est. Completion 2019-05-16

What the finished NCT02129140 record still lists

NCT02129140 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Hernia graft/mesh is the first listed.

NCT02129140 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02129140 about?

NCT02129140 is a clinical study titled "Observational Study to Evaluate Ventral Incisional Hernia Repair Using a Biologic Mesh (Cook Biodesign)". The purpose of this study is to evaluate the efficacy of the Cook Biodesign mesh for the repair of complex ventral incisional hernias. Using materials to reinforce tissue defects is indicated as standard of care for this type of surgery. The Cook Biodesign mesh is currently FDA-approved for implanta...

What is the current status of trial NCT02129140?

This trial is currently completed. The enrollment target is 30 participants. The study started on 2014-04. Estimated completion is 2019-05-16.

What interventions are being tested in trial NCT02129140?

The interventions under investigation include: Hernia graft/mesh (DEVICE).

Who is sponsoring clinical trial NCT02129140?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02129140, the US trial registry maintained by the National Library of Medicine. NCT02129140 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.