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NCT05744414 · ClinicalTrials.gov registry record
Histological Analysis of AlloMend® Acellular Dermal Matrix Used in Breast Implant Surgeries
A clinical trial of Breast Implant; Complications, Infection or Inflammation, sponsored by AlloSource.
- Active
- Registry status
- 30
- Enrollment target
- 1
- Study location
NCT05744414: Active study of Breast Implant; Complications, Infection or Inflammation, sponsored by AlloSource.
NCT05744414 is a study of Breast Implant; Complications, Infection or Inflammation that is active but no longer recruiting, run by AlloSource. The registered enrollment target is 30 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05744414, a study of Breast Implant; Complications, Infection or Inflammation, is active but no longer recruiting, sponsored by AlloSource.
- ACTIVE NOT RECRUITING
- Registry status
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a prospective, histologic analysis of biopsied tissue obtained from participants who have undergone a pre-pectoral breast reconstruction or augmentation surgery with expander placement and AlloMend® Acellular Dermal Matrix. AlloMend® Acellular Dermal Matrix graft incorporation with surrounding native soft tissue using histological assays characterizing host cell infiltration, neovascularization, inflammation, and host replacement of ADM collagen will be studied.
Primary Outcome
The primary endpoint being evaluated in this study is AlloMend® Acellular Dermal Matrix graft incorporation when used in a soft tissue application. The endpoint will be analyzed from biopsied tissue samples taken during the exchange of expander to permanent breast implant using histological assays characterizing host cell infiltration, neovascularization, inflammation, and host replacement of ADM collagen.
Conditions Studied
Study Locations (1)
Nevada
- Janiga MDs Plastic Surgery and Cosmetic Center - Reno
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-05-17 |
| Est. Completion | 2026-05 |
What the registry record for NCT05744414 still lists
NCT05744414 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target.
The record links to 1 condition, with Breast Implant; Complications, Infection or Inflammation appearing as the primary indexed condition, and to 0 interventions.
NCT05744414 reports a single indexed study location in Nevada.
Frequently Asked Questions
What is clinical trial NCT05744414 about?
NCT05744414 is a clinical study titled "Histological Analysis of AlloMend® Acellular Dermal Matrix Used in Breast Implant Surgeries". This is a prospective, histologic analysis of biopsied tissue obtained from participants who have undergone a pre-pectoral breast reconstruction or augmentation surgery with expander placement and AlloMend® Acellular Dermal Matrix. AlloMend® Acellular Dermal Matrix graft incorporation with surround...
What is the current status of trial NCT05744414?
This trial is currently active not recruiting. The enrollment target is 30 participants. The study started on 2023-05-17. Estimated completion is 2026-05.
What conditions does trial NCT05744414 study?
This clinical trial studies the following conditions: Breast Implant; Complications, Infection or Inflammation.
Who is sponsoring clinical trial NCT05744414?
This trial is sponsored by AlloSource, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05744414 being conducted?
This trial has 1 study location across Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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