PowerSpiral Enteroscopy Performance and Safety

Small Bowel Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04884113
• Other study ID #: W20.204
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: April 2023
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Intestinal Diseases
• Small Bowel Disease

Intervention

Device:
• Motorized Spiral enteroscopy
Small-bowel enteroscopy for diagnosis and intervention

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

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