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

PowerSpiral Enteroscopy Performance and Safety

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20350
Enrollment
130
Registered
2021-05-03
Start date
2020-03-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small-Bowel diseases requiring enteroscopy for diagnosis or interventions. The majority are vascular disease with bleeding.

Interventions

Performing enteroscopy using the motorized powerspiral for diagnosis and management of small bowel disease. For example, dilatations of stenosis or performing endotherapy for bleeding lesions. In addi

Sponsors

St Antonious hospital, Postbus 2500, 3430 EM, Nieuwegein, The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age above 18 years 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

Exclusion criteria: 1. Contraindications for endoscopy because of comorbidities 2. Unable to provide written informed consent 3. Patients with known severe gastro-intestinal 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

Design outcomes

Primary

MeasureTime frame
The primary aim of this study was to evaluate the efficacy in terms of diagnostic and therapeutic yield of PSE in patients undergoing enteroscopy by both antegrade and/or retrograde approaches for suspected small-bowel disease.

Secondary

MeasureTime frame
Secondary objectives were to evaluate the total enteroscopy rate, technical success, procedural time, depth of maximum insertion, performance in patients with altered GI anatomy and adverse events.

Contacts

Public ContactAbdulbaqi Al-Toma

St Antonious hospital, Postbus 2500, 3430 EM, Nieuwegein, The Netherlands

a.altoma@antoniusziekenhuis.nl0883205660

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)