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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05975359
The ClinicalTrials.gov registry entry for NCT05975359 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 130-participant average among 8 other Mastectomy trials with a reported enrollment target (85% lower). The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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