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NCT06073808 · ClinicalTrials.gov registry record · NA

The Role of Amnion Membrane Allografts in Nipple Preservation

A NA study, sponsored by Stanford University.

Not yet
Registry status
NA
Development phase
30
Enrollment target

NCT06073808: Clinical Trial NA study, sponsored by Stanford University.

NCT06073808 is a NA study that has not yet begun recruiting, run by Stanford University. The registered enrollment target is 30 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

NCT06073808, a NA study, has not yet begun recruiting, sponsored by Stanford University.

NOT YET RECRUITING
Registry status
NA
Development phase
30 participants
Enrollment target

Study Summary

The overall objective of this proposal is to conduct a randomized-controlled study to determine whether treatment with dehydrated human amnion/chorion membrane (dHACMs) allografts can improve NAC viability in patients undergoing nipple sparing mastectomy (NSM). dHACM allografts are commercially available tissue membranes with biocompatible extracellular matrix and growth factors that have been shown to improve wound healing in patients with chronic and lower extremity wounds. To date, no study has evaluated the impact of dHACMs on NAC preservation following NSM. Investigators hypothesize that subareolar surgical implantation of dHACM allografts at time of NSM will reduce NAC necrosis and improve viability.

Primary Outcome

The primary endpoint of this study is number of nipples with necrosis as defined by dark blue or black nipple discoloration, ultimately resulting in scabs or open wounds up to 3 months post-operatively.

Interventions

  • DEVICE Control Device
  • DEVICE AmnioFix dehydrated Human Amnion/Chorion Membrane Allograft

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2026-06-01
Est. Completion 2026-09
Phase NA
Stanford University

1,744 total trials

What is known before NCT06073808 opens enrollment

NCT06073808 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 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 Control Device is the first listed.

NCT06073808 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06073808 about?

NCT06073808 is a clinical study titled "The Role of Amnion Membrane Allografts in Nipple Preservation". The overall objective of this proposal is to conduct a randomized-controlled study to determine whether treatment with dehydrated human amnion/chorion membrane (dHACMs) allografts can improve NAC viability in patients undergoing nipple sparing mastectomy (NSM). dHACM allografts are commercially avai...

What is the current status of trial NCT06073808?

This trial is currently not yet recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2026-06-01. Estimated completion is 2026-09.

What interventions are being tested in trial NCT06073808?

The interventions under investigation include: Control Device (DEVICE), AmnioFix dehydrated Human Amnion/Chorion Membrane Allograft (DEVICE).

Who is sponsoring clinical trial NCT06073808?

This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06073808's enrollment target sits among peer trials

30 1593rd of 2000 higher than 299 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 NCT06073808, the US trial registry maintained by the National Library of Medicine. NCT06073808 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.