NCT07268365 Is Cap Assisted Endoscopy Useful in Acute Upper Gastrointestinal Bleeding ?
| NCT ID | NCT07268365 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Condition | Cap-assisted Endoscopy |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2025-10-16 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 72 participants in total. It began in 2025-10-16 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
High digestive bleeding (HDH) is a medical emergency associated with high morbidity and mortality rates and significant healthcare costs. Upper endoscopy can locate the bleeding and treat it. However, the source of bleeding can be difficult to identify, even for the most experienced endoscopists, due to the location of the bleeding (posterior wall of the bulb, gastric or duodenal folds, papillary region, esophagogastric junction), instability of the tube due to gastric and pyloric contractions and respiratory movements, leading to longer procedure times, hemostasis failure, or even the absence of bleeding visualization. The use of a cap attached to the endoscope facilitates exploration of blind areas of the colonic mucosa located behind folds, thus reducing the rate of missed polyps and cecal intubation time. To date, there is no study evaluating the systematic use of a cap in patients with suspected high digestive bleeding. A series of four cases demonstrated its benefit, allowing for better exposure of the bleeding lesion, better unfolding of intestinal folds, and thus a more effective and quicker hemostatic treatment.
Eligibility Criteria
Inclusion Criteria: * Patient \> 18 years old * Upper GI bleeding suspected in presence of melena or hematemesis * Glasgow Blatchford score \> 8 * Upper gastroscopy at Amiens University Hospital * Follow-up at Amiens university hospital * Presence of gastric or duodenal ulcer requiring endoscopic hemostasis (FORREST Ia, Ib, IIa, IIb) * No opposition to the study * No guardianship or curators Exclusion Criteria: * Patient with clinical suspicion of portal hypertension * Known liver failure * Patient with digestive hemorrhage related to a lesion located beyond the 2nd duodenum * Patient with digestive hemorrhage related to a varicose lesion (esophageal or gastric varices) * Patient with bleeding associated with esophagitis * Patient with bleeding associated with angiodysplasias
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07268365 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cap-assisted Endoscopy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07268365 currently recruiting?
Yes, NCT07268365 is actively recruiting participants. Contact the research team at yzet.clara@chu-amiens.fr for enrollment information.
Where is the NCT07268365 trial being conducted?
This trial is being conducted at Amiens, France.
Who is sponsoring the NCT07268365 clinical trial?
NCT07268365 is sponsored by Centre Hospitalier Universitaire, Amiens. The trial plans to enroll 72 participants.