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NCT02838316 · ClinicalTrials.gov registry record · Phase 1
Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) for Tongue Dysphagia
A Phase 1 study of Oropharyngeal Dysphagia, sponsored by Peter Belafsky, MD.
- Active
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT02838316: Active Phase 1 study of Oropharyngeal Dysphagia, sponsored by Peter Belafsky, MD.
NCT02838316 is a Phase 1 study of Oropharyngeal Dysphagia that is active but no longer recruiting, run by Peter Belafsky, MD. The registered enrollment target is 18 participants, below the 108-participant average among 7 other Oropharyngeal Dysphagia trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02838316, a Phase 1 study of Oropharyngeal Dysphagia, is active but no longer recruiting, sponsored by Peter Belafsky, MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of this study is to evaluate the safety of Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) during the 12 months following treatment of tongue dysphagia in male and female patients who have undergone surgery and/or chemo- and/or radiotherapy for squamous cell cancer of the oropharynx.
Primary Outcome
Evaluate the safety of AMDC-GIR following treatment of tongue dysphagia
Conditions Studied
Interventions
- DRUG Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR)
Study Locations (1)
California
- UC Davis Medical Center, Department of Otolaryngology, Head and Neck Surgery - Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2017-05-24 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What the registry record for NCT02838316 still lists
NCT02838316 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 108-participant average among 7 other Oropharyngeal Dysphagia trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Oropharyngeal Dysphagia appearing as the primary indexed condition, and to 1 intervention - of which Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) is the first listed.
NCT02838316 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02838316 about?
NCT02838316 is a clinical study titled "Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) for Tongue Dysphagia". The primary objective of this study is to evaluate the safety of Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) during the 12 months following treatment of tongue dysphagia in male and female patients who have undergone surgery and/or chemo- and/or radiotherapy for squamous ...
What is the current status of trial NCT02838316?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2017-05-24. Estimated completion is 2026-12.
What conditions does trial NCT02838316 study?
This clinical trial studies the following conditions: Oropharyngeal Dysphagia.
What interventions are being tested in trial NCT02838316?
The interventions under investigation include: Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) (DRUG).
Who is sponsoring clinical trial NCT02838316?
This trial is sponsored by Peter Belafsky, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02838316 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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