New treatment option for Postoperative Pain
Official title RADA16 for Adult Tonsillectomy
ClinicalTrials.gov ID: NCT07060495
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults undergoing tonsillectomy (CPT codes)
You likely can't join if
- 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
See the full eligibility criteria
- Adults undergoing tonsillectomy (CPT codes)
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Livingston, New Jersey, United States
- Newark, New Jersey, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Livingston, New Jersey, United States; Newark, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.