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Completed

NCT Number: NCT04895254

Colonoscopy Using Motorized Spiral Enteroscope

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

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Key information

Conditions

Colon Disease Colonic Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Centre Groningen, Groningen, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic colonoscopy

Device

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

Therapeutic colonoscopy

Procedure

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

Primary outcomes

  1. evaluate the feasibility of motorized PowerSpiral enteroscopy for difficult colonoscopies

    Time frame: during procedure

    achieving cecum intubation in difficult colons

  2. evaluate the safety of motorized PowerSpiral enteroscopy for difficult colonoscopies

    Time frame: 7 days

    Registering adverse events

Secondary outcomes

  1. Endoscopic mucosal resection

    Time frame: during procedure

    Performing endoscopic mucosal resection on polyps

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Registry information

Official study title

Colonoscopy Using Motorized Spiral Enteroscope: Prospective Bi-center Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 20, 2021
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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