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New treatment option for Ischemic Bowel Disease
Official title Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease
ClinicalTrials.gov ID: NCT07621367
What this study is testing
- What it's testing
- This multicenter, randomized, double-blind, placebo-controlled clinical trial aimed to investigate the efficacy and safety of gut oxygen therapy in the treatment of ischemic-hypoxic bowel disease using deep intestinal catheterization as a targeted route for gut oxygen delivery.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Clinical diagnosis of intestinal ischemia and hypoxia-related diseases caused by conditions such as ischemic bowel disease, heart failure, etc...
- At least able to perform bedside activities and able to defecate in conventional positions (sitting or squatting).
- Age ≥18 years, and able to voluntarily sign informed consent.
You likely can't join if
- Acute intestinal emergencies such as acute intestinal obstruction, intestinal perforation, or active massive gastrointestinal bleeding.
- Intestinal fistula.
- History of abdominal surgery within the recent past (\<1 month).
- Severe uncontrolled arrhythmia or respiratory failure.
- Cardiac function Class IV (NYHA Class IV).
- Patients with abnormal visceral pressure sensitivity.
See the full eligibility criteria
- Clinical diagnosis of intestinal ischemia and hypoxia-related diseases caused by conditions such as ischemic bowel disease, heart failure, etc., presenting with recurrent or persistent abdominal pain and/or distension...
- At least able to perform bedside activities and able to defecate in conventional positions (sitting or squatting).
- Age ≥18 years, and able to voluntarily sign informed consent.
- Acute intestinal emergencies such as acute intestinal obstruction, intestinal perforation, or active massive gastrointestinal bleeding.
- Intestinal fistula.
- History of abdominal surgery within the recent past (\<1 month).
- Severe uncontrolled arrhythmia or respiratory failure.
- Cardiac function Class IV (NYHA Class IV).
- Patients with abnormal visceral pressure sensitivity.
- Inability to cooperate with study assessments.
- Other conditions that, in the opinion of the investigator, make the subject unsuitable for inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.