NCT06579040Recruiting
The HEROES Trial: Hyperbaric Oxygen Therapy for Endometriosis-Related Pain
The HEROES Trial: Hyperbaric Oxygen Therapy for Endometriosis-Related Pain: A Prospective Randomized Study
Source: ClinicalTrials.gov · Last updated 15 Apr 2026
Brief summary (registry, in English)
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 pain, infertility and other symptoms. This can affect a woman's quality of life (including increased risk of depression and anxiety) and is associated with increased healthcare costs. Current treatments are often limited by serious side effects, and many women resort to surgery. Surgery is also associated with complications and there are long wait times for procedures, sometimes over 3 years. This means that many women continue to suffer from symptoms while they wait for surgery. Therefore, new effective treatments for endometriosis pain are needed. New research suggests that inflammation and stress caused by lack of oxygen in the affected areas may cause endometriosis. Hyperbaric Oxygen Therapy (HBOT), where patients are placed in a small chamber with higher than normal levels of oxygen, suppresses inflammation and promotes tissue healing. Because inflammation is central to this condition, HBOT has emerged as a potential treatment. In this study, the investigators will test if HBOT, in addition to the standard treatments, is more effective at treating endometriosis pain than the standard treatments alone.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- First submitted
- 9 Aug 2024
- Start date
- 8 Apr 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Diseases
- Endometriosis
- NCT number
- NCT06579040
What you commit to
- Study type: Interventional
- Planned participants: 64
- From 8 Apr 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Other
- Unlikely to comply with follow-up assessments (e.g. no fixed address, plans to move out of town)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.