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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00025890
Enrollment
32
Registered
2021-07-28
Start date
2021-08-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K63.8 K92.2

Interventions

Group 1: Motorized spiral: In advance, all patients with indication for enteroscopy are screened. Inclusion and exclusion criteria are observed. The patient has to sign informed consent the day befor

Sponsors

Medizinische Klinik 1 Universitätsmedizin Frankfurt
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Secondary

MeasureTime frame
Complication

Primary

MeasureTime frame
Time to achieve diagnosis or complete enteroscopy.

Countries

Germany

Contacts

Public ContactMate Knabe

Medizinische Klinik 1 , Universitäsklinik Frankfurt

Mate.knabe@kgu.de+49 69 63 01 - 172368

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026