๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-21

Impact of RADA16 Use on Outcomes Following Tonsillectomy in Children (NCT07188779)

๐ŸŸข Recruiting Phase2 โš™๏ธ Medical Device Protocol Sponsor: Rutgers, The State University of New Jersey

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The purpose of the research is to determine if RADA16 (also known as PuraStatยฎ, PuraGelยฎ, or PuraSinusยฎ) 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.

Who can join: Review the eligibility criteria below.

Location: Cooperman Barnabas Medical Center โ€” Livingston, New Jersey

Age range: 3 Years to 17 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (2 Sites)

  • Cooperman Barnabas Medical Center โ€” Livingston, New Jersey
  • University Hospital โ€” Newark, New Jersey

๐Ÿ“ž Contact the Study Coordinator

Phone: (973) 972-4588

Email: wayne.hsueh@rutgers.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—