| NCT ID | NCT07060495 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Rutgers, The State University of New Jersey |
| Condition | Postoperative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 134 participants |
| Start Date | 2025-09-12 |
| Primary Completion | 2026-12-01 |
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.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 134 participants in total. It began in 2025-09-12 with a primary completion date of 2026-12-01.
⚠ 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 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.
Eligibility Criteria
Inclusion criteria: Adults undergoing tonsillectomy (CPT codes) Exclusion criteria: Patients undergoing adenoidectomy or uvulopalatopharyngoplasty in addition to tonsillectomy Patients who have had prior tonsillectomy or tonsillotomy Patient undergoing tonsillectomy with concern for malignancy Patients who are on opioids chronically prior to surgery Patients with an additional indication for pain management (i.e. unrelated to tonsillectomy) Patients who have been diagnosed with a bleeding disorder or hematologic malignancy Patients who are on anticoagulants The following at-risk populations: Anyone under age 18 Pregnant women Prisoners Adults unable to consent (anyone lacking capacity)
Contact & Investigator
Wayne D Hsueh, MD
PRINCIPAL INVESTIGATOR
Rutgers University
Frequently Asked Questions
Who can join the NCT07060495 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, 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 NCT07060495 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 134 participants.
Is NCT07060495 currently recruiting?
Yes, NCT07060495 is actively recruiting participants. Contact the research team at wayne.hsueh@rutgers.edu for enrollment information.
Where is the NCT07060495 trial being conducted?
This trial is being conducted at Livingston, United States, Newark, United States.
Who is sponsoring the NCT07060495 clinical trial?
NCT07060495 is sponsored by Rutgers, The State University of New Jersey. The principal investigator is Wayne D Hsueh, MD at Rutgers University. The trial plans to enroll 134 participants.