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CompletedNCT04895254Updated Jun 21, 2022

Colonoscopy Using Motorized Spiral Enteroscope

An observational study in Colon Disease, sponsored by St. Antonius Hospital. Completed at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-21.

Sponsored by St. Antonius Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
36
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Colon Disease

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Keywords

  • Motorized Spiral enteroscopy
  • colonoscopy
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In context

Colonic Diseases

147 studies on the registry are indexed under Colonic Diseases; 23 are open to participants now.

This study's enrollment of 36 is below the median of 165 across 51 observational studies indexed under Colonic Diseases.

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Lead sponsor

St. Antonius Hospital is the lead sponsor of 97 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with failed colonoscopies using the conventional standrad colonoscopy devices.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
36 participants (actual)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • Experimental: Motorized spiral Enteroscopy

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

    Device: Diagnostic colonoscopy · Procedure: Therapeutic colonoscopy

Interventions

  • DeviceDiagnostic colonoscopy

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

  • ProcedureTherapeutic colonoscopy

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

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What researchers measure

Primary outcomes

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

    achieving cecum intubation in difficult colons

    Time frame: during procedure

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

    Registering adverse events

    Time frame: 7 days

Secondary outcomes

  1. Endoscopic mucosal resection

    Performing endoscopic mucosal resection on polyps

    Time frame: during procedure

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Study locations

2 sites
  • University Medical Centre Groningen
    Groningen, 9700 RB, Netherlands
  • St Antonius hospital
    Nieuwegein, 3430 EM, Netherlands
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04895254
Lead sponsor
St. Antonius Hospital
Responsible party
Abdulbaqi Al-Toma (Principal investigator, St. Antonius Hospital) — Principal investigator
First posted
May 20, 2021
Start date
May 25, 2021
Primary completion
May 31, 2022
Completion
May 31, 2022
Last update
Jun 21, 2022

Study contacts

Abdulbaqi Al-Toma, Ph.D.
principal investigator · St. Antonius Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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