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RADA16 for Adult Tonsillectomy

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. 3 versions Re-verified since Apr 16, 2026, no change to tracked fieldsv7-v9
  2. Primary and study completion dates: Sep 1, 2026 to Dec 1, 2026v6
  3. Re-verified, no change to tracked fieldsv5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Sep 15, 2025 to Sep 12, 2025
    v4
  5. Start date: Sep 1, 2025 to Sep 15, 2025v3
  6. Start date: Aug 1, 2025 to Sep 1, 2025
    • Primary and study completion dates: Aug 1, 2026 to Sep 1, 2026
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of the research is to determine if RADA16 (also known as PuraStat®, PuraGel®, or PuraSinus®) improves patient outcomes following tonsillectomy procedures. Researchers will compare application of device RADA16 to application of no device to see if RADA16 works to treat post tonsillectomy hemorrhage. Participants will: * Undergo tonsillectomy procedure. * Receive and fill out a survey sent via email every 2 days following their procedure for 15 days and track their symptoms.
Trial Details
NCT Number NCT07060495
Lead Sponsor Rutgers, The State University of New Jersey
Conditions
(from sponsor)		 Postoperative Pain
Related terms Postoperative Pain
Enrollment 134 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov