NCT07188779 Impact of RADA16 Use on Outcomes Following Tonsillectomy in Children
| NCT ID | NCT07188779 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Rutgers, The State University of New Jersey |
| Condition | Postoperative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 134 participants |
| Start Date | 2026-07-09 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 134 participants in total. It began in 2026-07-09 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: Children aged 3-17 years undergoing tonsillectomy +/- adenoidectomy CPT codes * 42820 (Tonsillectomy and adenoidectomy; younger than age 12) * 42821 (… age 12 or over) * 42825 (Tonsillectomy; primary or secondary; younger than age 12) * 42826 (… age 12 or over) * 42830 (Adenoidectomy, primary; younger than age 12) * 42831 (… age 12 or over) * 42835 (Adenoidectomy; secondary; younger than age 12) * 42836 (… age 12 or over) Exclusion Criteria: * Children with bleeding disorders or other hematologic malignancy or taking anticoagulant medications Developmental delay affecting pain reporting Children with known allergies to RADA16 components Children with prior tonsillectomy or tonsillotomy Children undergoing tonsillectomy with concern for cancer, Children taking opioids chronically prior to surgery, Anyone pregnant women, incarcerated individuals, children unable to speak English or Spanish
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07188779 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 17 Years, studying Postoperative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07188779 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07188779 currently recruiting?
Yes, NCT07188779 is actively recruiting participants. Contact the research team at wayne.hsueh@rutgers.edu for enrollment information.
Where is the NCT07188779 trial being conducted?
This trial is being conducted at Livingston, United States, Newark, United States.
Who is sponsoring the NCT07188779 clinical trial?
NCT07188779 is sponsored by Rutgers, The State University of New Jersey. The trial plans to enroll 134 participants.