deltatrials
Terminated NA INTERVENTIONAL 2-arm NCT01910298

Efficacy Study of Single Stage Breast Reconstruction in Female Participants With Mastectomy (ESSBR)

A Prospective, Multicenter, Controlled Study of Implant-based Breast Reconstruction, Measuring the Safety, Efficacy and Outcomes, of Immediate Single Stage Breast Reconstruction With Strattice™ Reconstructive Tissue Matrix Versus Immediate Two Stage Breast Reconstruction Without Strattice™ TM (ESSBR-Efficacy of Single Stage Breast Reconstruction)

Sponsor: LifeCell

Updated 8 times since 2017 Last updated: Nov 14, 2019 Started: Jul 29, 2013 Primary completion: Aug 31, 2016 Completion: Oct 23, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

The study is being terminated due to no enrollment in over one year in the control arm

This NA trial investigates Mastectomy and Breast Reconstruction and is currently terminated or withdrawn. LifeCell leads this study, which shows 8 recorded versions since 2013 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Apr 2017 · 3 months · monthly snapshotTerminated~Apr 2017 – ~Jun 2018 · 14 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2020 · 19 months · monthly snapshotTerminated~Jan 2020 – ~Jan 2021 · 12 months · monthly snapshotTerminated~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotTerminated~Sep 2025 – present · 10 months · monthly snapshotTerminated

Change History

8 versions recorded
  1. Sep 2025 — Present [monthly]

    Terminated NA

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated NA

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated NA

  4. Jan 2021 — Jul 2024 [monthly]

    Terminated NA

  5. Jan 2020 — Jan 2021 [monthly]

    Terminated NA

Show 3 earlier versions
  1. Jun 2018 — Jan 2020 [monthly]

    Terminated NA

  2. Apr 2017 — Jun 2018 [monthly]

    Terminated NA

  3. Jan 2017 — Apr 2017 [monthly]

    Terminated NA

    First recorded

Jul 2013

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • LifeCell
Data source: LifeCell

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