Last reviewed · How we verify
NCT04051892
Multicenter Study Evaluating the FixNip™ NRI Safety and Performance
NA trial testing FixNip™ NRI in Reconstruction of the Breast Nipple and Areola Complex in 10 participants. Completed in 22 December 2022.
13 July 2022
Quick facts
| Lead sponsor | FixNip Ltd |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 10 |
| Start date | 6 October 2020 |
| Primary completion | 13 July 2022 |
| Estimated completion | 22 December 2022 |
| Sites | 1 location across Israel |
Drugs / interventions tested
- FixNip™ NRI
Conditions studied
- Reconstruction of the Breast Nipple and Areola Complex — all drugs for Reconstruction of the Breast Nipple and Areola Complex →
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):
-
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
Verify or expand the search:
- PubMed search for NCT04051892
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04051892 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by FixNip Ltd
- Last refreshed: 21 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04051892.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing