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

November 4, 2026 updated by: FixNip Ltd

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson
        • Contact:
        • Principal Investigator:
          • Olenczak

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female Subject age 22 years or older
  • Subject of childbearing potential must agree to use medically accepted methods of contraception throughout the study and have a negative pregnancy test at screening
  • History of breast cancer treated with total mastectomy only, with implant-based or autologous breast reconstruction seeking reconstruction of the nipple-areolar complex.
  • Local tissue thickness at the intended nipple location of at least 10 mm, confirmed by both pinch test and ultrasound-based assessment. Tissue thickness requirement must extend across the entire implant coverage area.
  • At least 12 months have elapsed since the last course of chemotherapy with absolute neutrophil count of ≥2
  • At least 12 months have elapsed since the last breast and nipple reconstruction surgery.
  • Local tissue thickness at the intended nipple location of at least 10 mm, confirmed by both pinch test and ultrasound-based assessment. Tissue thickness requirement must extend across the entire implant coverage area.
  • At least 12 months have elapsed since the last course of chemotherapy with absolute neutrophil count of ≥2
  • At least 12 months have elapsed since the last breast and nipple reconstruction surgery.

Exclusion Criteria:

  • Subject with active malignant disease.
  • Subject undergoing active treatment with targeted therapies or immunotherapies (e.g. Abemaciclib, Pembrolizumab)
  • Any medical condition that in the opinion of the investigator may be associated with unduly high risk of intra-or post-operative complications (e.g., insulin dependent diabetes, connective tissue disorder, chronic lung or severe cardiovascular disease).
  • Any history of radiation therapy to the chest wall or the breast(s). Subjects with a residual native nipple- areola complex, including those who have undergone nipple-sparing mastectomy.
  • Any history of failed nipple flap reconstruction
  • Subjects with a residual native nipple-areola complex, including those who have undergone nipple-sparing mastectomy.
  • Subjects who are currently using tissue expanders or who plan to undergo tissue expander placement during the study period.
  • History of hypertrophic scarring or keloid formation.
  • Current use of any medications that can interfere with wound healing, impair the immune system functionality or impair blood clotting mechanisms.
  • Active infection within the last 90 days.
  • Subject who is pregnant, nursing, or planning pregnancy during the study period.
  • Subject with known connective tissue disease.
  • Diagnosis of the following rheumatic diseases or syndromes with the patient on systemic treatmen systemic lupus erythematosus, Sjogren's syndrome, scleroderma, polymyositis or any connective tissue disorder, rheumatoid arthritis crystalline arthritis, arthritis, infec infections arthritis, spondyloarthropathies, and any other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome.
  • Subject is chronically treated with steroids or had steroid therapy in the past 3 months prior to the study (regardless of route of administration).
  • Subjects exhibiting psychological characteristics that, in the opinion of the Investigator and/or consulting physician(s) is incompatible with the risks associated with the surgical procedure, prosthesis, and compliance with protocol requirements.
  • Past or current capsular contracture, defined as Baker III or IV
  • Subject who is currently participating in, or has participated in, any other investigational drug or device study within 90 days prior to enrollment will be excluded, to allow an appropriate washout period and to ensure the valid collection and interpretation of data under this protocol.
  • Subject with known allergies to silicone and/ or nitinol.
  • Subjects who are current smokers or who have used nicotine-containing products (including cigarettes, e-cigarettes/vaping, cigars, pipes, nicotine patches, or chewing tobacco) within 3 months prior to enrollment will be excluded, due to the increased risk of impaired wound healing and skin and soft tissue ischemia.
  • Any condition that, in the Investigator's opinion, would preclude the use of the study device, interfere with the evaluation of the device or breast related outcomes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Feasibility

NRI implantation
Device: NRI implantation

NRI implantation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility study under an Investigational Device Exemption (IDE)
Time Frame: 12 months

This feasibility study is intended to generate device-performance data to inform the design of a subsequent pivotal clinical study.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nipple Projection Outcomes
Time Frame: 12 months

Maintenance of nipple projection at 12 months post Fixnip NRI implantation procedure compared to nipple projection measurement at 4-6 weeks post FixNip NRI implantation procedure (Visit 4)
12 months
Patient Satisfaction
Time Frame: 12 months

"Final Score" of Nipple Specific Adjusted BREAST-Q QoL Questionnaire at 6- and 12- months post procedure.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
FixNip Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PREFIX-FS-CP-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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