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NCT04662632 · ClinicalTrials.gov registry record · Phase 2
Abbreviated Protocol for Two-Stage Exchange
A Phase 2 study, sponsored by Osteal Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 76
- Enrollment target
NCT04662632 is a Phase 2 study that has completed, run by Osteal Therapeutics. The registered enrollment target is 76 participants.
The verdict
NCT04662632, a Phase 2 study, has completed, sponsored by Osteal Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 76 participants
- Enrollment target
Study Summary
Study Type: A multi-site, parallel group, randomized trial. Study Objectives: The objective is to evaluate safety and determine preliminary efficacy of VT-X7 (Vancomycin and Tobramycin Exchanged over 7 Days). Efficacy is evaluated as superiority of the Experimental Arm in a composite endpoint of Overall Success at 90 days, consisting of a revision prosthesis implanted at Stage 2, patient survival, absence of reoperation and absence of periprosthetic joint infection (PJI). Secondary objectives are to evaluate superiority at 365 days in a composite endpoint of Overall Success, and in separate secondary endpoints for quality of life and patient survival. The exploratory objective is to compare Experimental and Control Arms in exploratory endpoints. Follow-up: Patients will be evaluated at 90-, 180-, and 365-day follow-up visits.
Interventions
- DRUG Standard of Care
- PROCEDURE Two-stage exchange arthroplasty
- COMBINATION_PRODUCT VT-X7 Treatment System with Tobramycin Sulfate
- COMBINATION_PRODUCT VT-X7 Treatment System with Vancomycin Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2021-11-01 |
| Est. Completion | 2023-12-22 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04662632
The ClinicalTrials.gov registry entry for NCT04662632 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Osteal Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Standard of Care is the first listed.
NCT04662632 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04662632 about?
NCT04662632 is a clinical study titled "Abbreviated Protocol for Two-Stage Exchange". Study Type: A multi-site, parallel group, randomized trial. Study Objectives: The objective is to evaluate safety and determine preliminary efficacy of VT-X7 (Vancomycin and Tobramycin Exchanged over 7 Days). Efficacy is evaluated as superiority of the Experimental Arm in a composite endpoint of Ov...
What is the current status of trial NCT04662632?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2021-11-01. Estimated completion is 2023-12-22.
What interventions are being tested in trial NCT04662632?
The interventions under investigation include: Standard of Care (DRUG), Two-stage exchange arthroplasty (PROCEDURE), VT-X7 Treatment System with Tobramycin Sulfate (COMBINATION_PRODUCT), VT-X7 Treatment System with Vancomycin Hydrochloride (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04662632?
This trial is sponsored by Osteal Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
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