A new clinical trial aims to explore the effectiveness of RADA16 hydrogel in mitigating postoperative pain for children undergoing tonsillectomy. Rutgers University is sponsoring this study, which seeks to examine this medical device’s impact on recovery outcomes.
As of October 5, 2025, recruitment for the trial has not yet begun. This research could be significant for clinical teams, regulatory professionals, and medical device developers interested in advancing pediatric care.
- What is RADA16 and why is it being studied?
- Clinical trial details: What to know
- FAQ
- Implications for healthcare professionals
- Disclaimer
- Full announcement and link
What is RADA16 and why is it being studied?
RADA16 hydrogel is a peptide-based biomaterial designed to support tissue healing and reduce pain. By forming a scaffold at the surgical site, the hydrogel aims to minimize irritation and support recovery. Tonsillectomy, a common pediatric procedure, often results in significant postoperative pain, making this area of research crucial.
The study intends to clinically assess the performance of RADA16 in reducing pain levels compared to standard care. This aligns with regulatory priorities to approve innovative technologies that address unmet medical needs in vulnerable populations like children.
Clinical trial details: What to know
Who is conducting the research?
This study is sponsored by Rutgers University, a leading institution in biomedical research. Their focus on medical devices in pediatric care highlights their expertise in advancing evidence-based solutions.
Trial phase and recruitment status
As of the current update, the trial is listed as “not yet recruiting” on ClinicalTrials.gov, under the identifier NCT07188779. The study design will likely include randomized comparisons to evaluate postoperative pain outcomes among participants receiving RADA16 hydrogel versus standard-of-care treatments.
Intended outcomes
By evaluating RADA16’s efficacy in reducing pain, researchers aim to provide actionable data for pediatricians and surgeons. Positive results could pave the way for regulatory clearance and wider use of this device in clinical practice.
FAQ
1. Is this trial enrolling participants now?
No, recruitment has not yet started as of October 2025. Updates will be made available on ClinicalTrials.gov.
2. Who can participate?
While specific inclusion criteria are still pending, the trial will focus on pediatric patients undergoing tonsillectomy.
3. Will RADA16 be commercially available after the trial?
Commercial availability will depend on the outcomes of this and any subsequent trials, as well as regulatory approval processes.
Implications for healthcare professionals
Clinical, quality, and regulatory teams should monitor this trial closely. Innovations like RADA16 have the potential to enhance surgical recovery efforts, making them an important consideration for future procedural standards in pediatric care.
Medical device companies may explore partnerships or similar technologies to address postoperative pain. If successful, the RADA16 hydrogel could set a benchmark for post-surgical interventions.
Disclaimer
This article is intended for informational purposes only and not as legal or medical advice. Consult relevant regulations and clinical guidance for compliance-related decisions.
Full announcement and link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07188779?term=medical+device