PREFIX FEASIBILITY Study - PRojection & Safety Evaluation of the FIXNip Nipple Reconstruction Implant

ClinicalTrials.gov ID: NCT07925034

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ClinicalTrials.gov public records Last synced Nov 15, 2026, 7:00 AM EST

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a prospective, single center, controlled, open-label feasibility IDE clinical study enrolling patients with a history of breast cancer who have previously undergone total mastectomy with breast reconstruction and are seeking nipple reconstruction.

Study identification

NCT ID: NCT07925034
Recruitment status: Recruiting
Study type: Interventional
Phase: Not applicable
Lead sponsor: FixNip Ltd; Industry
Enrollment: 5 participants

Conditions and interventions

Conditions

Breast Reconstruction After Mastectomy

Interventions

NRI implantation Device

Device

Eligibility (public fields only)

Age range: 22 Years and older
Sex: Female
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 1, 2026 (Estimated)
Primary completion: Feb 15, 2028 (Estimated)
Completion: Apr 2028 (Estimated)
Last update posted: Nov 9, 2026

2026 – 2028

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
MD Anderson	Houston	Texas	77030	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07925034, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 9, 2026 · Synced Nov 15, 2026