Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05975359 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Assessment of the Interi Manifold in Implant-Based Breast Reconstruction

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing Show 7 more changesShow less
    • Final enrollment: 9 participants (planned 20)
    • Primary completion date changed from estimate of Sep 2026 to Jun 11, 2026
    • Study completion pushed from Sep 2026 to Jun 2027
    • Start date: Oct 5, 2023 to Sep 5, 2023
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 1 of 5 entries
    • Site details revised
  2. Primary and study completion dates: Mar 2026 to Sep 2026v7
  3. Primary and study completion dates: Sep 2025 to Mar 2026
    • Collaborator revised
    v6
  4. Primary and study completion dates: Aug 2024 to Sep 2025v5
  5. Eligibility criteria expanded, about 2 wordsv4
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 2023 to Oct 5, 2023
    • Site details revised
    v3
  2. Study title shortened, about 2 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Patients with breast cancer that elect to undergo implant-based breast reconstruction (IBBR) often require the placement of a surgical drain. Surgical drains are used to manage dead space and prevent seroma formation or accumulation of fluid within the surgical field postoperatively. The most frequently used drain is a Jackson-Pratt (JP) drain, which is limited by poor surgical site coverage and low capacity, leading to inconsistent suction and prolonged time that a drain is left in place. The Interi Drain system is a novel, multi-branched manifold with a proprietary suction system that provides consistent suction and addresses many of the shortcoming of JP drains. The purpose of this study is to compare the Interi system to standard JP drains across outcomes including number of surgical drain sites, complication rates, time to drain removal, time to initiate tissue expansion, total fluid volume drained, and patient satisfaction.
Trial Details
NCT Number NCT05975359
Lead Sponsor Stanford University
Collaborators: IC Surgical, Inc.
Conditions
(from sponsor)		 Mastectomy, Implant Based Breast Reconstruction
Enrollment 9 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov