Motorized Spiral enteroscopy
DeviceSmall-bowel enteroscopy for diagnosis and intervention
NCT Number: NCT04884113
Multicenter study to evaluate the efficacy of the motorized spiral enteroscope in the management of small bowel diseases.
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Notify Me18 year and older
All sexes
Observational
VU University Medical Center, Amsterdam, Netherlands
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Small-bowel enteroscopy for diagnosis and intervention
Time frame: 2 days
Diagnostic yield achieved by antegrade and/or retrograde enteroscopy using motorized spiral enteroscopy
Time frame: 2 days
Total number of therapeutic interventions performed during antegrade and/or retrograde enteroscopy using the motorized spiral enteroscopy
Time frame: 2 days
Estimate the number of total enteroscopy procedures achieved by either antegrade only or antegrade and retrograde motorized spiral enteroscopy
Time frame: 2 days
Estimate the rate of technically successful enteroscopy procedures both antegrade and retrograde motorized spiral enteroscopy
Time frame: 2 days
The total time needed to complete the whole procedure of enteroscopy antegrade and/or retrograde motorized spiral enteroscopy
Time frame: 2 days
Estimation of the maximum depth of insertion (in centimeters) both antegrade and/or retrograde motorized spiral enteroscopy
Time frame: 7 days
Total minor and also serious adverse events during and after antegrade and/or retrograde motorized spiral enteroscopy
St. Antonius Hospital
Other
PowerSpiral Enteroscopy: Multicenter Prospective Study on Performance and Safety Including Patients With Altered Gastrointestinal Anatomy
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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