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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 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.

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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.

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

What the Registry Record Tells You About NCT04293146

The ClinicalTrials.gov registry entry for NCT04293146 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 382 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 373-participant average among 18 other Breast Reconstruction trials with a reported enrollment target. The listed sponsor is University Hospital, Basel, Switzerland, which has 12 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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