deltatrials
Completed NA INTERVENTIONAL 2-arm NCT03737500

Standard Silicone-based vs. B-Lite® Light Weight Breast Implant After Total Mastectomy and Radiotherapy for Breast Cancer (BLITE-01)

Standard Silicone-based Breast Implant vs. B-Lite® Light Weight Breast Implant for Reconstructive Surgery After Total Mastectomy and Post-Mastectomy Radiotherapy for Breast Cancer: a Randomized Clinical Trial

Sponsor: Istituti Clinici Scientifici Maugeri SpA

Updated 6 times since 2018 Last updated: Mar 17, 2023 Started: Jun 1, 2018 Primary completion: Apr 30, 2021 Completion: Jun 30, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A NA clinical study on Breast Cancer and Breast Implant Protrusion, this trial is completed. The trial is conducted by Istituti Clinici Scientifici Maugeri SpA and has accumulated 6 data snapshots since 2018. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Dec 2018 – ~Jan 2021 · 25 months · monthly snapshotRecruiting~Jan 2021 – ~Apr 2022 · 15 months · monthly snapshotRecruiting~Apr 2022 – ~Apr 2023 · 12 months · monthly snapshotActive Not Recruiting~Apr 2023 – ~Jul 2024 · 15 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

6 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed NA

  2. Jul 2024 — Sep 2024 [monthly]

    Completed NA

  3. Apr 2023 — Jul 2024 [monthly]

    Completed NA

    Status: Active Not RecruitingCompleted

  4. Apr 2022 — Apr 2023 [monthly]

    Active Not Recruiting NA

    Status: RecruitingActive Not Recruiting

  5. Jan 2021 — Apr 2022 [monthly]

    Recruiting NA

Show 1 earlier version
  1. Dec 2018 — Jan 2021 [monthly]

    Recruiting NA

    First recorded

Jun 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Istituti Clinici Scientifici Maugeri SpA
Data source: Istituti Clinici Scientifici Maugeri SpA

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations