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Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy OPBC-02PREPEC
NCT04293146 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 382 participants |
| Start Date | 2020-07-28 |
| Est. Completion | 2033-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04293146
The ClinicalTrials.gov registry entry for NCT04293146 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 382 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Hospital, Basel, Switzerland, which has 10 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04293146 reports 20 study locations spanning 2 distinct geographic areas — top geographies include Other, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04293146?
The interventions under investigation include: pre-pectoral IBBR (PROCEDURE), sub-pectoral IBBR (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04293146?
This trial is sponsored by University Hospital, Basel, Switzerland, which has 10 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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