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Multicenter Study Evaluating the FixNip™ NRI Safety and Performance

NCT04051892 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-03-21

No results posted yet for this study

Summary

A prospective, Open Label, Single arm, Multicenter study Evaluating the FixNip™ NRI Safety and Performance in Female Patients Seeking Reconstructive Surgery of the Nipple.

Conditions

  • Reconstruction of the Breast Nipple and Areola Complex

Interventions

DEVICE

FixNip™ NRI

The FixNip™ NRI is an implantable hypodermic, silicone implant specially designed for nipple areola definition

Sponsors & Collaborators

  • FixNip Ltd

    lead INDUSTRY

Principal Investigators

  • Michael Scheflan, MD · Assuta MC

  • Ariel Tessone, MD · Sheba MC

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-06
Primary Completion
2022-07-13
Completion
2022-12-22

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04051892 on ClinicalTrials.gov