Status:
COMPLETED
PowerSpiral Enteroscopy Performance and Safety
Lead Sponsor:
St. Antonius Hospital
Conditions:
Small Bowel Disease
Eligibility:
All Genders
18+ years
Brief Summary
Multicenter study to evaluate the efficacy of the motorized spiral enteroscope in the management of small bowel diseases.
Detailed Description
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 ut...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT04884113
Start Date
March 1 2020
End Date
March 1 2022
Last Update
April 26 2023
Active Locations (5)
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1
VU University Medical Center
Amsterdam, Netherlands, 6813KJ
2
University Medical Centre Groningen
Groningen, Netherlands, 9700 RB
3
Leiden University Medical Centre
Leiden, Netherlands, 2311ZN
4
Maastricht UMC+
Maastricht, Netherlands, 6202 AZ