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NCT04060134 · ClinicalTrials.gov registry record

A Retrospective Breast Reconstruction Study

A clinical trial, sponsored by Elutia.

Completed
Registry status
223
Enrollment target

NCT04060134: Completed study, sponsored by Elutia.

NCT04060134 is a clinical trial that has completed, run by Elutia. The registered enrollment target is 223 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04060134 has completed, sponsored by Elutia.

COMPLETED
Registry status
223 participants
Enrollment target

Study Summary

To collect data on patients who have previously undergone breast reconstruction utilizing SimpliDerm and other HADMs.

Primary Outcome

Occurrence of: infection, hematoma, seroma, capsular contracture, mastectomy skin flap dehiscence, mastectomy skin flap necrosis, expander/implant explantation, red breast syndrome, subsequent surgical interventions related to the breast reconstruction process

Interventions

  • OTHER SimpliDerm HADM
  • OTHER AlloDerm HADM
  • OTHER AlloMax HADM
  • OTHER FlexHD HADM
  • OTHER DermACELL HADM

Trial Details

FieldValue
Enrollment Target 223 participants
Start Date 2019-11-20
Est. Completion 2022-06-01
Elutia

10 total trials

What the finished NCT04060134 record still lists

NCT04060134 is an observational study that tracks outcomes without assigning an intervention. The registered 223 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 5 interventions - of which SimpliDerm HADM is the first listed.

NCT04060134 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04060134 about?

NCT04060134 is a clinical study titled "A Retrospective Breast Reconstruction Study". To collect data on patients who have previously undergone breast reconstruction utilizing SimpliDerm and other HADMs.

What is the current status of trial NCT04060134?

This trial is currently completed. The enrollment target is 223 participants. The study started on 2019-11-20. Estimated completion is 2022-06-01.

What interventions are being tested in trial NCT04060134?

The interventions under investigation include: SimpliDerm HADM (OTHER), AlloDerm HADM (OTHER), AlloMax HADM (OTHER), FlexHD HADM (OTHER), DermACELL HADM (OTHER).

Who is sponsoring clinical trial NCT04060134?

This trial is sponsored by Elutia, which has 10 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT04060134, the US trial registry maintained by the National Library of Medicine. NCT04060134 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.