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Impact of RADA16 Use on Outcomes Following Tonsillectomy in Children

Study acronym: RADA16 for Ped
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date changed from estimate of Jul 1, 2026 to Jul 9, 2026v5
  2. Start date: May 1, 2026 to Jul 1, 2026v4
  3. Recruitment opened
    • Start date: Apr 1, 2026 to May 1, 2026
    • Study sites: 0 to 2
    v3
  4. Primary completion date: Dec 1, 2026 to Dec 1, 2027
    • Start date: Dec 1, 2025 to Apr 1, 2026
    • Study completion date: May 1, 2027 to Dec 1, 2027
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 pediatric 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, plus an additional survey on day 30, and track their symptoms.
Trial Details
NCT Number NCT07188779
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