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NCT05898074 · ClinicalTrials.gov registry record · NA
Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery
A NA study of Skull Base Neoplasms and Cerebrospinal Fluid Leakage, sponsored by Indiana University.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05898074: Recruiting NA study of Skull Base Neoplasms and Cerebrospinal Fluid Leakage, sponsored by Indiana University.
NCT05898074 is a NA study of Skull Base Neoplasms and Cerebrospinal Fluid Leakage that is actively recruiting participants, run by Indiana University. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05898074, a NA study of Skull Base Neoplasms and Cerebrospinal Fluid Leakage, is actively recruiting participants, sponsored by Indiana University.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Modified Lund-Kennedy nasal endoscopy score to rate mucosal edema, nasal crusting, and scarring. This will be double blinded (video endoscopy will be performed and scoring will be performed by non-operative surgeon, blinded to the intervention group). This scoring will address wound healing, adhesion formations. Scoring will be performed at 1 week, 4 weeks, and 12 weeks following surgery. The timing of these assessments is based on the routine postoperative follow-up schedule. No additional appo
Conditions Studied
Interventions
- DEVICE Non-Absorbable Packing (Silastic Splint)
- DEVICE PuraGel (RADA16) Hydrogel
Study Locations (1)
Indiana
- Indiana University - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-10-09 |
| Est. Completion | 2025-10-09 |
| Phase | NA |
What NCT05898074 shows while recruiting
NCT05898074 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Skull Base Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which Non-Absorbable Packing (Silastic Splint) is the first listed.
NCT05898074 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT05898074 about?
NCT05898074 is a clinical study titled "Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery". 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.
What is the current status of trial NCT05898074?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2023-10-09. Estimated completion is 2025-10-09.
What conditions does trial NCT05898074 study?
This clinical trial studies the following conditions: Skull Base Neoplasms, Cerebrospinal Fluid Leakage, Nasal; Hypertrophy, Mucous Membrane (Septum).
What interventions are being tested in trial NCT05898074?
The interventions under investigation include: Non-Absorbable Packing (Silastic Splint) (DEVICE), PuraGel (RADA16) Hydrogel (DEVICE).
Who is sponsoring clinical trial NCT05898074?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05898074 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05898074's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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