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Rhu-pGSN to Mitigate Proinflammatory Responses to Decompression in Healthy SCUBA Divers
NCT06216366 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG 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
- OTHER Hyperbaric chamber
Study Locations (1)
Maryland
- University of Maryland School of Medicine — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2025-08-15 |
| Est. Completion | 2025-12-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06216366
The ClinicalTrials.gov registry entry for NCT06216366 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioAegis Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Decompression Sickness appearing as the primary indexed condition, and to 5 interventions — of which Sodium Chloride 0.9% Inj pre-exposure is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06216366 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06216366 about?
NCT06216366 is a clinical study titled "Rhu-pGSN to Mitigate Proinflammatory Responses to Decompression in Healthy SCUBA Divers". 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 no...
What is the current status of trial NCT06216366?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2025-08-15. Estimated completion is 2025-12-30.
What conditions does trial NCT06216366 study?
This clinical trial studies the following conditions: Decompression Sickness. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06216366?
The interventions under investigation include: 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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06216366?
This trial is sponsored by BioAegis Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06216366 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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