RADA16 for Adult Tonsillectomy
Recruiting
Phase 3
Interventional Study
Postoperative Pain
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 134 (estimated)
- Sponsor
- Rutgers, The State University of New Jersey · Other
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About This Trial
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…
Trial Locations
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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
…
Contacts