Video Capsule Endoscopy for Detection of Gastrointestinal Bleeding in the Small Bowel

NCT05949268 | Recruiting

• 1 other identifier: Capsule endoscopy_FR
• Study Type: observational
• Target: 1,300
• Locations: 1 country
• Sites: 1

Brief Summary

Small bowel capsule endoscopy is the main diagnostic standard for small bowel bleeding. This study investigates the detection rate of small bowel bleeding in capsule endoscopy and further endoscopic treatment in a prospective and retrospective cohort.

Conditions

GastroIntestinal Bleeding

Keywords

Small bowel capsule endoscopy; gastrointestinal bleeding; anticaogulation

Outcome Measures

Primary Outcomes (1)

• Prevalence of small bowel bleeding detected during small bowel capsule endoscopy

  Detection of bleeding during small bowel capsule endoscopy

  Through study completion, an average of 1 year

Secondary Outcomes (6)

• Prevalence of vascular lesions as source of bleeding

  Through study completion, an average of 1 year

• Prevalence of inflammatory lesions as source of bleeding

  Through study completion, an average of 1 year

• Prevalence of tumor lesions as source of bleeding

  Through study completion, an average of 1 year

• Complications of small bowel capsule endoscopy

  Through study completion, an average of 1 year

• Technical success of small bowel capsule endoscopy

  Through study completion, an average of 1 year

Study Arms (1)

Patients with gastrointestinal bleeding undetected in gastroscopy and colonoscopy

Gastrointestinal bleeding in the small bowel.

Device: Small bowel capsule endoscopy

Interventions

Small bowel capsule endoscopy DEVICE

Patients with gastrointestinal bleeding receive small bowel capsule endoscopy after bleeding could not be located in gastroscopy or colonoscopy.

Patients with gastrointestinal bleeding undetected in gastroscopy and colonoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who present with gastrointestinal bleeding undetected in gastroscopy or colonoscopy will be included in this cohort study. In these patients bleeding in the small bowel is suspected and they are allocated to a diagnostic assessment with small bowel capsule endoscopy.

You may qualify if:

• suspicion of gastrointestinal bleeding in the small bowel undetected by gastroscopy and colonoscopy
• informed consent

You may not qualify if:

• contraindications for small bowel capsule endoscopy (e.g. stenosis)

Sponsors & Collaborators

• University Hospital Freiburg: lead

Study Sites (1)

University Medical Center Freiburg, Department of Medicine II

Freiburg im Breisgau, 79106, Germany

RECRUITING

Related Publications (1)

• Rondonotti E, Spada C, Adler S, May A, Despott EJ, Koulaouzidis A, Panter S, Domagk D, Fernandez-Urien I, Rahmi G, Riccioni ME, van Hooft JE, Hassan C, Pennazio M. Small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and treatment of small-bowel disorders: European Society of Gastrointestinal Endoscopy (ESGE) Technical Review. Endoscopy. 2018 Apr;50(4):423-446. doi: 10.1055/a-0576-0566. Epub 2018 Mar 14.

  PMID: 29539652 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Michael Schultheiss, MD

  University Medical Center Freiburg, Department of Medicine II, Freiburg, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Schultheiss, MD

CONTACT

+49761/270-34010; michael.schultheiss@uniklinik-freiburg.de

Dominik Bettinger, MD

CONTACT

+49761/270-36870; dominik.bettinger@uniklinik-freiburg.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 18, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): July 15, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)