Rhu-pGSN to Mitigate Proinflammatory Responses to Decompression in Healthy SCUBA Divers
Public ClinicalTrials.gov record NCT06216366. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety/Tolerability of IV Rhu-pGSN as a Pre- or Post-Exposure Intervention to Mitigate Proinflammatory Responses to Decompression After High Pressure in a Hyperbaric Chamber
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Healthy trained SCUBA divers will be randomized into three groups and exposed to a high-pressure profile in a hyperbaric chamber. The high-pressure profile simulates the pressure at a depth of 30 meters of sea water (MSW) for 35 minutes. In the control group, the subjects will receive intravenous normal saline immediately before and after the high-pressure exposure. The second group will receive intravenous recombinant human gelsolin (rhu-pGSN) 24 mg/kg immediately prior to the exposure, and saline post-exposure. The third group will receive saline pre-exposure and rhu-pGSN post-exposure. Blood samples will be collected at multiple time points pre- and post-exposure to assess levels of inflammatory markers, including interleukin (IL)-1β. Other assessments include screening for gas bubbles, a validated questionnaire to assess the incidence of clinical decompression sickness (DCS), measurement of plasma gelsolin (pGSN) levels, and measurement of anti-pGSN antibodies.
Study identification
- NCT ID
- NCT06216366
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 36 participants
Conditions and interventions
Conditions
Interventions
- Sodium Chloride 0.9% Inj pre-exposure Drug
- Sodium Chloride 0.9% Inj post-exposure Drug
- Recombinant human plasma gelsolin pre-exposure Drug
- Recombinant human plasma gelsolin post-exposure Drug
- Hyperbaric chamber Other
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 14, 2025
- Primary completion
- Oct 29, 2025
- Completion
- Dec 29, 2025
- Last update posted
- Oct 14, 2025
2025
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Maryland School of Medicine | Baltimore | Maryland | 21201 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06216366, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 14, 2025 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06216366 live on ClinicalTrials.gov.