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NCT01597128 · ClinicalTrials.gov registry record · NA

Feasibility Study of The Use of FLEX HD® Surgical Implant or STRATTICE® Reconstructive Tissue Matrix in The Closure of Abdominal Wall Defects With Component Separation in Clean or Contaminated Cases

A NA study, sponsored by John Roth.

Completed
Registry status
NA
Development phase
35
Enrollment target

NCT01597128: Completed NA study, sponsored by John Roth.

NCT01597128 is a NA study that has completed, run by John Roth. The registered enrollment target is 35 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01597128, a NA study, has completed, sponsored by John Roth.

COMPLETED
Registry status
NA
Development phase
35 participants
Enrollment target

Study Summary

This study examines the feasibility of using Flex HD® Surgical Implant or STRATTICE® Reconstructive Tissue Matrixin the repair of hernias.

Primary Outcome

Recurrence of hernia based on physical exam and /or CT scan.

Interventions

  • DEVICE Strattice
  • DEVICE Flex HD

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2011-03
Est. Completion 2015-05
Phase NA
John Roth

2 total trials

What the finished NCT01597128 record still lists

NCT01597128 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which Strattice is the first listed.

NCT01597128 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01597128 about?

NCT01597128 is a clinical study titled "Feasibility Study of The Use of FLEX HD® Surgical Implant or STRATTICE® Reconstructive Tissue Matrix in The Closure of Abdominal Wall Defects With Component Separation in Clean or Contaminated Cases". This study examines the feasibility of using Flex HD® Surgical Implant or STRATTICE® Reconstructive Tissue Matrixin the repair of hernias.

What is the current status of trial NCT01597128?

This trial is currently completed. It is a NA study. The enrollment target is 35 participants. The study started on 2011-03. Estimated completion is 2015-05.

What interventions are being tested in trial NCT01597128?

The interventions under investigation include: Strattice (DEVICE), Flex HD (DEVICE).

Who is sponsoring clinical trial NCT01597128?

This trial is sponsored by John Roth, which has 2 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01597128's enrollment target sits among peer trials

35 1564th of 2000 higher than 431 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01597128, the US trial registry maintained by the National Library of Medicine. NCT01597128 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.