Colonoscopy Using Motorized Spiral Enteroscope

NCT ID: NCT04895254

Last Updated: 2022-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-25

Study Completion Date

2022-05-31

Brief Summary

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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

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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.

Conditions

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Colon Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Experimental: Motorized spiral Enteroscopy

Consecutive patients with difficult colonoscopies to be enrolled to achieve total colonoscopy using the motorized spiral enteroscope.

Diagnostic colonoscopy

Intervention Type DEVICE

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

Therapeutic colonoscopy

Intervention Type PROCEDURE

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

Interventions

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Diagnostic colonoscopy

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

Intervention Type DEVICE

Therapeutic colonoscopy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Antonius Hospital

OTHER

Sponsor Role lead

Responsible Party

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Abdulbaqi Al-Toma

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abdulbaqi Al-Toma, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

St. Antonius Hospital

Locations

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University Medical Centre Groningen

Groningen, , Netherlands

Site Status

St Antonius hospital

Nieuwegein, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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W2021.204

Identifier Type: -

Identifier Source: org_study_id

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