Multicenter, prospective, randomized study comparing motorized spiral enteroscopy with double balloon enteroscopy

Not Applicable

• Conditions: K63.8; K92.2; Other specified diseases of intestine; Gastrointestinal haemorrhage, unspecified

• Registration Number: DRKS00025890
• Lead Sponsor: Medizinische Klinik 1 Universitätsmedizin Frankfurt

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Clinical indication for performing a small bowel eteroscopy
• Age 18+
• signed declaration of consent

Exclusion Criteria

Exclusion criteria
• Medical instability preventing anesthesia
• No possibility of obtaining consent
• Known perforation
• Uncontrolled coagulopathy
• Recent nutritional jejunostomy (e.g., less than two weeks ago)
• Pediatric patients, especially infants and young children
• Patients who have had a stent or other element implanted in the intestinal tract that could obstruct the passage of the PowerSpiral disposable overtube.
With antegrade access
• Perforated ulcer
• Esophageal or gastric varices
• Stenosis in the foregut region
• Deep laceration of the mucosa
• Suspected or diagnosed eosinophilic esophagitis
• Inability to tolerate a mouthpiece
With retrograde access
• Severe active inflammation of the colon
• Anal stenosis
• Colon structure
• Planned enteroscopy with the aim of ERCP after previous surgery

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to achieve diagnosis or complete enteroscopy.

Secondary Outcome Measures

Name	Time	Method
Complication