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NCT05975359 · ClinicalTrials.gov registry record · NA
Assessment of the Interi Manifold in Implant-Based Breast Reconstruction
A NA study of Mastectomy and Implant Based Breast Reconstruction, sponsored by Stanford University.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05975359: Recruiting NA study of Mastectomy and Implant Based Breast Reconstruction, sponsored by Stanford University.
NCT05975359 is a NA study of Mastectomy and Implant Based Breast Reconstruction that is actively recruiting participants, run by Stanford University. The registered enrollment target is 20 participants, below the 130-participant average among 8 other Mastectomy trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05975359, a NA study of Mastectomy and Implant Based Breast Reconstruction, is actively recruiting participants, sponsored by Stanford University.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Incidence of adverse events or complications (e.g. seroma, hematoma, infection, dehiscence, etc.) will be recorded for both drain systems.
Conditions Studied
Interventions
- DEVICE Interi Manifold Drain System
- DEVICE Jackson Pratt Drain System
Study Locations (1)
California
- Stanford Hospital and Clinics - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-10-05 |
| Est. Completion | 2026-03 |
| Phase | NA |
What NCT05975359 shows while recruiting
NCT05975359 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 130-participant average among 8 other Mastectomy trials with a reported enrollment target (85% lower).
The record links to 2 conditions, with Mastectomy appearing as the primary indexed condition, and to 2 interventions - of which Interi Manifold Drain System is the first listed.
NCT05975359 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05975359 about?
NCT05975359 is a clinical study titled "Assessment of the Interi Manifold in Implant-Based Breast Reconstruction". 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 freque...
What is the current status of trial NCT05975359?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2023-10-05. Estimated completion is 2026-03.
What conditions does trial NCT05975359 study?
This clinical trial studies the following conditions: Mastectomy, Implant Based Breast Reconstruction.
What interventions are being tested in trial NCT05975359?
The interventions under investigation include: Interi Manifold Drain System (DEVICE), Jackson Pratt Drain System (DEVICE).
Who is sponsoring clinical trial NCT05975359?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05975359 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Mastectomy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05975359's enrollment target sits among peer trials
20 7th of 8 higher than 2 of 8 other Mastectomy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mastectomy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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