Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT05898074

Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery

Led by Indiana University · Updated on 2026-04-09

30

Participants Needed

1

Research Sites

139 weeks

Total Duration

On this page

Sponsors

I

Indiana University

Lead Sponsor

3

3-D Matrix UK Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to specifically evaluate the effectiveness of PuraGel, a RADA16 polypeptide hydrogel, in expediting post-operative healing and re-mucosalization of the nasoseptal flap harvest site during endoscopic skull base surgery and the impact on patient and sinonasal morbidity.

CONDITIONS

Official Title

Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is 18 years of age or older
  • Patient is undergoing endoscopic endonasal approach for management of a skull base tumor or cerebrospinal fluid leak with nasoseptal flap harvest
  • Surgery involves a bi-nostril approach requiring bilateral surgical dissection of the nasal cavity to the skull base
Not Eligible

You will not qualify if you...

  • Evidence of radiographic baseline sinus disease including acute or chronic rhinosinusitis, nasal polyposis, or prior septal perforation on pre-operative CT sinus
  • Prior sinonasal surgery or sinonasal radiation treatment
  • Known coagulation disorder or immune deficiency

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
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Trial Site Locations

Total: 1 location

1

Indiana University

Indianapolis, Indiana, United States, 46202

Actively Recruiting

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Research Team

S

Satyan Sreenath, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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