Rhu-pGSN to Mitigate Proinflammatory Responses to Decompression in Healthy SCUBA Divers (NCT06216366) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Rhu-pGSN to Mitigate Proinflammatory Responses to Decompression in Healthy SCUBA Divers
United States36 participantsStarted 2025-08-15
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Experienced healthy trained female or male SCUBA divers without known underlying comorbidities
. Age ≥18
. Informed consent obtained from subject
. During the course of the study starting at screening and for at least 3 months after their final study treatment:
Exclusion criteria
. Any co-morbidity contraindicating SCUBA diving
. Pregnant or lactating women
. History of unrepaired cardiac shunt or echocardiographic evidence of patent foramen ovale or atrial septal defect
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Interleukin (IL)-1β
Timeframe: At baseline, during and after exposure, and afterward at 60, 120, and 240 minutes, at 24 hours, and at day 14
. Any active underlying conditions including but not limited to cancer or other illness treated with systemic chemotherapy, immunomodulatory biologics, or radiation therapy during the last 360 days or expected to be treated in the upcoming 120 days
. Refusal or inability to use adequate contraception
. Participation in an investigational clinical trial (e.g., device, drug, or biologic) in the previous 30 days
. Any acute illness or vaccination in the previous 30 days
. History of alcohol or recreation drug use disorder