Status:
RECRUITING
The HEROES Trial: Hyperbaric Oxygen Therapy for Endometriosis-Related Pain
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Endometriosis-related Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Endometriosis, is a condition where tissue from the uterus, called endometrium, grows outside of the uterus. This effects up to 10% of women, and can lead to long-lasting, moderate to severe pelvic pa...
Detailed Description
Endometriosis is caused when endometrial-like tissue is found outside of the uterus. It predominantly affects women of reproductive age, with an estimated prevalence of 10% worldwide. Chronic pain rel...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old
- Patients having refractory pelvic pain (NRS≥4) secondary to endometriosis for \>6 months
- May or may not be on traditional multi-modal treatment (pharmacological and/or non-pharmacological)
- On waitlist for surgical treatment
Exclusion
- Patients with chronic pain resulting from disease processes unrelated to the pathophysiology of endometriosis-related symptoms (e.g. irritable bowel syndrome, migraine headache, fibromyalgia, chronic low back pain, and musculoskeletal injuries)
- Contraindications/medically unfit to receive hyperbaric treatments at an outpatient facility (e.g. pneumothorax, in-patients, requiring infusions to maintain hemodynamics, active and unstable coronary disease)
- Unlikely to comply with follow-up assessments (e.g. no fixed address, plans to move out of town)
Key Trial Info
Start Date :
April 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06579040
Start Date
April 8 2025
End Date
December 1 2027
Last Update
September 9 2025
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5