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NCT04051892

Multicenter Study Evaluating the FixNip™ NRI Safety and Performance

Completed NA Last updated 21 March 2023
What this trial tests

NA trial testing FixNip™ NRI in Reconstruction of the Breast Nipple and Areola Complex in 10 participants. Completed in 22 December 2022.

Timeline
6 October 2020
Primary endpoint
13 July 2022
22 December 2022

Quick facts

Lead sponsorFixNip Ltd
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment10
Start date6 October 2020
Primary completion13 July 2022
Estimated completion22 December 2022
Sites1 location across Israel

Drugs / interventions tested

Conditions studied

Sponsor

FixNip Ltd

Who can join

Adults 22 to 70, female only, with Reconstruction of the Breast Nipple and Areola Complex. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Nipple Reconstruction Using FixNip NRI: A Novel Nipple Reconstruction Implant (First-in-human Trial).
    Konfino T, Scheflan LM, Caspi J, Stuchiner B, et al · · 2025 · cited 1× · PMID 40995572 · DOI 10.1097/gox.0000000000007103

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing