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Colonoscopy Using Motorized Spiral Enteroscope

Colonoscopy Using Motorized Spiral Enteroscope: Prospective Bi-center Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04895254
Enrollment
36
Registered
2021-05-20
Start date
2021-05-25
Completion date
2022-05-31
Last updated
2022-06-21

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

Conditions

Colon Disease

Keywords

Motorized Spiral enteroscopy, colonoscopy

Brief summary

The new technology of the motorized Spiral enteroscope, originally developed for deep small bowel enteroscopy, might potentially overcome some limitations of standard colonoscopy.

Detailed description

Cecal intubation rate represents a key procedural quality parameter in diagnostic colonoscopy. However, even in experienced hands, a significant percentage of colonoscopies (1.6-16.7%) remain incomplete because of a failure to intubate the cecum. The new technology of the motorized Spiral enteroscope, originally developed for deep small bowel enteroscopy, might potentially overcome some limitations of standard colonoscopy. The study aim was to evaluate the feasibility and safety of motorized Spiral enteroscopy for difficult colonoscopies.

Interventions

The feasibility of the motorized spiral enteroscope to achieve cecum intubation in difficult colons.

The feasibility of the motorized spiral enteroscope for performing interventions such as polypectomy

Sponsors

St. Antonius Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

\- Indications for Spiral colonoscopy as a rescue procedure because of incomplete antecedent colonoscopy

Exclusion criteria

* Age under 18 years * Known pregnancy * Poor health status (ASA classification ≥ 4) * Contraindication for sedation or standard colonoscopy * Known coagulopathy (INR ≥ 2.0, platelets \< 70 /nl) or anticoagulants other than aspirin * Medical history of chronic inflammatory bowel disease or suspected bowel obstruction

Design outcomes

Primary

MeasureTime frameDescription
evaluate the feasibility of motorized PowerSpiral enteroscopy for difficult colonoscopiesduring procedureachieving cecum intubation in difficult colons
evaluate the safety of motorized PowerSpiral enteroscopy for difficult colonoscopies7 daysRegistering adverse events

Secondary

MeasureTime frameDescription
Endoscopic mucosal resectionduring procedurePerforming endoscopic mucosal resection on polyps

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026