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Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from The Second Hospital of Nanjing Medical University

Record History

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  1. Primary endpoint(s) modifiedv2 Show 7 more changesShow less
    • Start date: May 28, 2026 to Aug 2, 2026
    • Enrollment increased: 90 → 100 participants
    • Interventions: Air (Other), Oxygen 30 % (Other) to Oxygen (O2) -Sham group (Other), Sham -Oxygen (O2) group (Other)
    • Eligibility criteria shortened, about 17 words
    • Secondary endpoints revised (5)
    • Publications: 4 to 3
    • Study description shortened, about 4 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This single-center, double-blind, randomized, intra-individual crossover controlled study aims to investigate the efficacy and safety of intestinal oxygen therapy via a deep intestinal catheter as a targeted route for intestinal oxygen delivery in the treatment of ischemic-hypoxic enteropathy, and simultaneously to explore and verify the chronobiological differences. Data have been obtained from the study based on the first version of our pilot study. Considering ethics and cost-effectiveness, a new protocol needs to be designed to achieve the research goals with minimal intervention, minimal cost, and the smallest sample size.
Trial Details
NCT Number NCT07621367
Lead Sponsor The Second Hospital of Nanjing Medical University
Conditions
(from sponsor)		 Chronic Ischemic-Hypoxic Enteropathy
Related terms Abdominal Pain, Heart Failure
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov