Small Bowel Disease Clinical Trial
Official title:
PowerSpiral Enteroscopy: Multicenter Prospective Study on Performance and Safety Including Patients With Altered Gastrointestinal Anatomy
NCT number | NCT04884113 |
Other study ID # | W20.204 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2020 |
Est. completion date | March 1, 2022 |
Verified date | April 2023 |
Source | St. Antonius Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Multicenter study to evaluate the efficacy of the motorized spiral enteroscope in the management of small bowel diseases.
Status | Completed |
Enrollment | 170 |
Est. completion date | March 1, 2022 |
Est. primary completion date | December 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age 18 years and older 2. Patients with suspected small bowel pathology indicated for diagnostic and/or therapeutic enteroscopy based on clinical presentation, small bowel imaging, or video capsule enteroscopy 3. Written informed consent Exclusion Criteria: 1. Contraindications for endoscopy because of comorbidities 2. Unable to provide written informed consent 3. Patients with known severe gastrointestinal tract inflammation, intestinal obstruction, gastroesophageal varices or eosinophilic esophagitis that preclude a safe enteroscopy procedure 4. Coagulopathy or thrombocytopenia that could not be corrected by blood product transfusion 5. Pregnant patients 6. Health status: American Society of Anesthesiologists (ASA) class >3 7. Inability to tolerate Propofol sedation or general anesthesia for any reason |
Country | Name | City | State |
---|---|---|---|
Netherlands | VU University Medical Center | Amsterdam | |
Netherlands | University Medical Centre Groningen | Groningen | |
Netherlands | Leiden University Medical Centre | Leiden | |
Netherlands | Maastricht UMC+ | Maastricht | |
Netherlands | St Antonius hospital | Utrecht |
Lead Sponsor | Collaborator |
---|---|
St. Antonius Hospital |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The diagnostic yield of motorized spiral enteroscopy | Diagnostic yield achieved by antegrade and/or retrograde enteroscopy using motorized spiral enteroscopy | 2 days | |
Primary | The therapeutic yield of motorized spiral enteroscopy | Total number of therapeutic interventions performed during antegrade and/or retrograde enteroscopy using the motorized spiral enteroscopy | 2 days | |
Secondary | Total enteroscopy rate | Estimate the number of total enteroscopy procedures achieved by either antegrade only or antegrade and retrograde motorized spiral enteroscopy | 2 days | |
Secondary | Technical success | Estimate the rate of technically successful enteroscopy procedures both antegrade and retrograde motorized spiral enteroscopy | 2 days | |
Secondary | Total procedural time | The total time needed to complete the whole procedure of enteroscopy antegrade and/or retrograde motorized spiral enteroscopy | 2 days | |
Secondary | Depth of maximum insertion into the small bowel | Estimation of the maximum depth of insertion (in centimeters) both antegrade and/or retrograde motorized spiral enteroscopy | 2 days | |
Secondary | Adverse events | Total minor and also serious adverse events during and after antegrade and/or retrograde motorized spiral enteroscopy | 7 days |
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