Skip to main content
OpenTrials
Completed

NCT Number: NCT04884113

PowerSpiral Enteroscopy Performance and Safety

Multicenter study to evaluate the efficacy of the motorized spiral enteroscope in the management of small bowel diseases.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

VU University Medical Center, Amsterdam, Netherlands

Loading trial locations.

About this study

Background and Aims:

Motorized Spiral enteroscopy is a recent advancement in enteroscopy. Data are scarce on the utility and safety of the motorized spiral enteroscopy. No data is available on the utility of this technique in patients with altered gastrointestinal (GI) anatomy.

This study aimed to evaluate the efficacy of motorized spiral enteroscopy including rate of total enteroscopy (TER) in patients undergoing enteroscopy for suspected small bowel disease including those with altered GI anatomy.

Methods: A multicenter prospective study evaluated consecutive patients with symptomatic small bowel disease who underwent enteroscopy over a 12-month period.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 years and older
  • Patients with suspected small bowel pathology indicated for diagnostic and/or therapeutic enteroscopy based on clinical presentation, small bowel imaging, or video capsule enteroscopy
  • Written informed consent

Exclusion criteria

  • Contraindications for endoscopy because of comorbidities
  • Unable to provide written informed consent
  • Patients with known severe gastrointestinal tract inflammation, intestinal obstruction, gastroesophageal varices or eosinophilic esophagitis that preclude a safe enteroscopy procedure
  • Coagulopathy or thrombocytopenia that could not be corrected by blood product transfusion
  • Pregnant patients
  • Health status: American Society of Anesthesiologists (ASA) class >3
  • Inability to tolerate Propofol sedation or general anesthesia for any reason

Treatment and study plan

Motorized Spiral enteroscopy

Device

Small-bowel enteroscopy for diagnosis and intervention

Primary outcomes

  1. The diagnostic yield of motorized spiral enteroscopy

    Time frame: 2 days

    Diagnostic yield achieved by antegrade and/or retrograde enteroscopy using motorized spiral enteroscopy

  2. The therapeutic yield of motorized spiral enteroscopy

    Time frame: 2 days

    Total number of therapeutic interventions performed during antegrade and/or retrograde enteroscopy using the motorized spiral enteroscopy

Secondary outcomes

  1. Total enteroscopy rate

    Time frame: 2 days

    Estimate the number of total enteroscopy procedures achieved by either antegrade only or antegrade and retrograde motorized spiral enteroscopy

  2. Technical success

    Time frame: 2 days

    Estimate the rate of technically successful enteroscopy procedures both antegrade and retrograde motorized spiral enteroscopy

  3. Total procedural time

    Time frame: 2 days

    The total time needed to complete the whole procedure of enteroscopy antegrade and/or retrograde motorized spiral enteroscopy

  4. Depth of maximum insertion into the small bowel

    Time frame: 2 days

    Estimation of the maximum depth of insertion (in centimeters) both antegrade and/or retrograde motorized spiral enteroscopy

  5. Adverse events

    Time frame: 7 days

    Total minor and also serious adverse events during and after antegrade and/or retrograde motorized spiral enteroscopy

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Registry information

Official study title

PowerSpiral Enteroscopy: Multicenter Prospective Study on Performance and Safety Including Patients With Altered Gastrointestinal Anatomy

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
May 12, 2021
Registry last updated
Apr 26, 2023

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.

Published trials that share one or more normalized conditions with this study.