Status:

RECRUITING

Ways of Retaining the Inframammary Fold in Implant-based Breast Surgery

Lead Sponsor:

Branch Office of "Hadassah Medical Ltd"

Collaborating Sponsors:

Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

Conditions:

Breast Cancer Stage I

Breast Cancer Stage II

Eligibility:

FEMALE

18+ years

Phase:

NA

Brief Summary

There is currently no consensus on the "gold standard" for Implant-based Breast reconstruction. In the United States, more than half of all breast reconstructions are performed using acellular dermal ...

Eligibility Criteria

Inclusion

  • White women;
  • Breast cancer stage 0-II;
  • Indications for breast reconstruction;
  • Consent to participate in the study and photographic documentation.

Exclusion

  • Non-white women;
  • Breast cancer stage III-IV;
  • Tubular breast;
  • Mental and cognitive health disorders;
  • Failure to comply with recommendations in the postoperative period (premature physical activity, not wearing compression underwear, missing scheduled visits, refusal of photo documentation);
  • Patient refusal to participate in the study at any stage.

Key Trial Info

Start Date :

March 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 1 2026

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT06931548

Start Date

March 1 2022

End Date

February 1 2026

Last Update

April 17 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

The Branch of Hadassah Medical LTD

Moscow, Skolkovo Innovation Center, Russia, 121205