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NCT Number: NCT06823414

Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy

Non-inferiority study of video-assisted (endoscopic or robotic) skin- and nipple-sparing mastectomy compared to open mastectomy. The feasibility of the technique, oncological safety and cosmetic results will be studied.

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Key information

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3) Breast Cancer Non-invasive Breast Cancer High Risk Breast Carcinoma

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Breast Unit. First floor. Hospital Abente y Lago. Paseo del General Sir John Moore, 4

A Coruña, Galicia, 15006, Spain

Location status: Recruiting

Location contact

Alejandra García Novoa, Ph.D

CONTACT

[email protected]

0034981178000 ext. 296158

Alejandra García Novoa, Ph.D

PRINCIPAL_INVESTIGATOR

Benigno Acea Nebril, Ph.D

PRINCIPAL_INVESTIGATOR

Benigno Acea Nebril, Ph.D.

CONTACT

[email protected]

+34981178000 ext. 296158

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women who require a mastectomy and who do not require skin reduction or resection are included. Women with both breast cancer and those at high risk for breast cancer are included.

Exclusion criteria

  • Sarcomas of the breast.
  • Benign breast tumors.
  • Prepectoral reconstruction with expansion.
  • Impossibility to preserve the skin.
  • Need for reduction pattern
  • Inability to perform an MRI during follow-up (obesity, claustrophobia, etc.).
  • Inability to complete the BREAST-Q™ questionnaire due to the patient's cognitive alterations.
  • Refusal of the patient to participate in the study.

Treatment and study plan

Video assisted mastectomy

Other

Nipple Skin sparing mastectomy assisted by endoscopic or robotic

Primary outcomes

  1. Implant Loss

    Time frame: First year after surgery

    Safety of the reconstruction technique, calculated by the number of implants lost

Secondary outcomes

  1. local relapse

    Time frame: first 5 years

    evaluate oncological safety in terms of local relapses

  2. Glandular residual tissue

    Time frame: first year

    Residual glandular tissue after endoscopic mastectomy identified by magnetic resonance imaging one year after the intervention

  3. Suvival

    Time frame: 5 years

    Overall survival

Study contacts

Contact information is provided by the study sponsor or research team.

Alejandra García Novoa, PhD MD

CONTACT

[email protected]

981178000 ext. 296113

Sponsors and collaborators

Lead sponsor

Alejandra García-Novoa

Other

Registry information

Official study title

Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy and Inmediate Reconstruction With Prepectoral Implant. Prospective Study for the Evaluation of the Feasibility and Safety of the Technique, Quality of Life and Cosmetic Results

Important dates

Study start
2025
Primary completion
2029
Study completion
2034
First posted
Feb 12, 2025
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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