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NCT05736848 · ClinicalTrials.gov registry record
A Retrospective Assessment of OviTex PRS (OviTex)
A clinical trial of Reconstructive Surgical Procedures, sponsored by Tela Bio.
- Recruiting
- Registry status
- 200
- Enrollment target
- 11
- Study locations
NCT05736848 is a study of Reconstructive Surgical Procedures that is actively recruiting participants, run by Tela Bio. The registered enrollment target is 200 participants. The trial reports 11 study locations across 8 states.
The verdict
NCT05736848, a study of Reconstructive Surgical Procedures, is actively recruiting participants, sponsored by Tela Bio.
- RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 11
- Study locations
Study Summary
The objective of this retrospective-prospective, observational study is to evaluate the safety profile overall and within two device types of OviTex PRS in previous pre-pectoral or sub-pectoral implant-based breast reconstructions.
Conditions Studied
Interventions
- DEVICE OviTex® PRS
Study Locations (11)
Florida
- Aesthetic Surgery Center - Naples
- Castrellon Aesthetic Surgery - South Miami
New Jersey
- David L. Abramson, MD - Englewood
- Capital Health - Pennington
Texas
- Dermatology Associates of San Antonio/Baptist Medical Center - San Antonio
- Houston Methodist The Woodlands Hospital - The Woodlands
Georgia
- Y Plastic Surgery - Alpharetta
Massachusetts
- Massachusetts General Hospital - Boston
Michigan
- Janineh Plastic Surgery - Rochester Hills
New York
- Strong Memorial Hospital - Rochester
South Carolina
- Plastic Surgery Consultants - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2022-09-27 |
| Est. Completion | 2026-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05736848
The ClinicalTrials.gov registry entry for NCT05736848 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tela Bio, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Reconstructive Surgical Procedures appearing as the primary indexed condition, and to 1 intervention - of which OviTex® PRS is the first listed.
NCT05736848 reports 11 study locations spanning 8 distinct geographic areas - top geographies include Florida, New Jersey, Texas.
Frequently Asked Questions
What is clinical trial NCT05736848 about?
NCT05736848 is a clinical study titled "A Retrospective Assessment of OviTex PRS (OviTex)". The objective of this retrospective-prospective, observational study is to evaluate the safety profile overall and within two device types of OviTex PRS in previous pre-pectoral or sub-pectoral implant-based breast reconstructions.
What is the current status of trial NCT05736848?
This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2022-09-27. Estimated completion is 2026-12-31.
What conditions does trial NCT05736848 study?
This clinical trial studies the following conditions: Reconstructive Surgical Procedures.
What interventions are being tested in trial NCT05736848?
The interventions under investigation include: OviTex® PRS (DEVICE).
Who is sponsoring clinical trial NCT05736848?
This trial is sponsored by Tela Bio, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05736848 being conducted?
This trial has 11 study locations across Florida, Georgia, Massachusetts, Michigan, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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