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NCT04293146 · ClinicalTrials.gov registry record · NA

Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy OPBC-02PREPEC

A NA study of Breast Reconstruction and Implant-Based Breast Reconstruction (IBBR), sponsored by University Hospital, Basel, Switzerland.

Active
Registry status
NA
Development phase
382
Enrollment target
20
Study locations

NCT04293146: Active NA study of Breast Reconstruction and Implant-Based Breast Reconstruction (IBBR), sponsored by University Hospital, Basel, Switzerland.

NCT04293146 is a NA study of Breast Reconstruction and Implant-Based Breast Reconstruction (IBBR) that is active but no longer recruiting, run by University Hospital, Basel, Switzerland. The registered enrollment target is 382 participants, roughly in line with the 373-participant average among 18 other Breast Reconstruction trials with a reported enrollment target. The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04293146, a NA study of Breast Reconstruction and Implant-Based Breast Reconstruction (IBBR), is active but no longer recruiting, sponsored by University Hospital, Basel, Switzerland.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
382 participants
Enrollment target
20
Study locations

Study Summary

This trial is to investigate whether pre-pectoral Implant-Based Breast Reconstruction (IBBR) provides better Quality of Life (QoL) with respect to long-term (24 months) physical well-being (chest) compared to sub-pectoral IBBR for patients undergoing skin-sparing mastectomy or nipple-sparing mastectomy for prevention or treatment of breast cancer.

Primary Outcome

compare the Quality of Life (QoL) with respect to long-term physical well-being (chest) after pre-pectoral or sub-pectoral IBBR. The BREAST-Q module specific to breast reconstruction version 2.0 consists of 13 independent scales covering health-related QoL domains and satisfaction domains. Each scale is scored to generate a numerical score on a scale from 0 (worst) to 100 (best).

Conditions Studied

Breast Reconstruction Implant-Based Breast Reconstruction (IBBR)

Interventions

  • PROCEDURE pre-pectoral IBBR
  • PROCEDURE sub-pectoral IBBR

Study Locations (20)

Other

  • Universitätsklinik für Frauenheilkunde und Geburtshilfe - Salzburg
  • Medizinische Universität Wien - Vienna
  • Evangelisches Krankenhaus BETHESDA zu Duisburg GmbH, Klinik für Frauenheilkunde, Geburtshilfe, Gynäkologische Onkologie & Senologie - Duisburg
  • KEM | Evang. Kliniken Essen-Mitte - Essen
  • Universitätsklinikum Heidelberg - Heidelberg
  • Landesfrauenklinik, Senologie und Brustzentrum - Wuppertal
  • National Institute of Oncology - Budapest
  • Universitario "Agostino Gemelli" di Roma, Unità Operativa di Chirurgia Senologica - Roma
  • Ospedale Santa Chiara, Breast Surgical Oncology/Oncoplastic Surgery. Breast Center - Trento
  • Capio S:t Görans Hospital - Stockholm
  • Södersjukhuset - Stockholm
  • Karolinska University Hospital - Stockholm
  • Klinik Hirslanden Brustzentrum Aarau - Aarau
  • Kantonsspital Aarau AG - Aarau
  • University Hospital Basel, Division of Breast Surgery - Basel
  • Universitätsklinik für Plastische- und Handchirurgie, Inselspital - Bern
  • Lindenhof Bern - Bern
  • Kantonsspital Frauenfeld - Frauenfeld
  • Gesundheitszentrum Fricktal - Rheinfelden

Massachusetts

  • Brigham and Women's Hospital Harvard Medical School - Boston

Trial Details

FieldValue
Enrollment Target 382 participants
Start Date 2020-07-28
Est. Completion 2033-02
Phase NA
University Hospital, Basel, Switzerland

12 total trials

What the registry record for NCT04293146 still lists

NCT04293146 is an interventional study that assigns participants to a tested intervention. The registered 382 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 373-participant average among 18 other Breast Reconstruction trials with a reported enrollment target.

The record links to 2 conditions, with Breast Reconstruction appearing as the primary indexed condition, and to 2 interventions - of which pre-pectoral IBBR is the first listed.

NCT04293146 names 20 study sites across 2 states, led by Other, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT04293146 about?

NCT04293146 is a clinical study titled "Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy OPBC-02PREPEC". This trial is to investigate whether pre-pectoral Implant-Based Breast Reconstruction (IBBR) provides better Quality of Life (QoL) with respect to long-term (24 months) physical well-being (chest) compared to sub-pectoral IBBR for patients undergoing skin-sparing mastectomy or nipple-sparing mastect...

What is the current status of trial NCT04293146?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 382 participants. The study started on 2020-07-28. Estimated completion is 2033-02.

What conditions does trial NCT04293146 study?

This clinical trial studies the following conditions: Breast Reconstruction, Implant-Based Breast Reconstruction (IBBR).

What interventions are being tested in trial NCT04293146?

The interventions under investigation include: pre-pectoral IBBR (PROCEDURE), sub-pectoral IBBR (PROCEDURE).

Who is sponsoring clinical trial NCT04293146?

This trial is sponsored by University Hospital, Basel, Switzerland, which has 12 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04293146 being conducted?

This trial has 20 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Breast Reconstruction

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04293146's enrollment target sits among peer trials

382 7th of 18 higher than 12 of 18 other Breast Reconstruction trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Reconstruction trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT04293146, the US trial registry maintained by the National Library of Medicine. NCT04293146 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.