PowerSpiral Enteroscopy Performance and Safety

• Sponsor: St. Antonius Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04884113
• Collaborator: (none)
• Enrollment: 170
• Locations: 5
• Anticipated Duration (Months): 33
• Patients Per Site: 34
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Small Bowel Disease	Device: Motorized Spiral enteroscopy

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 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.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 170 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: PowerSpiral Enteroscopy: Multicenter Prospective Study on Performance and Safety Including Patients With Altered Gastrointestinal Anatomy
• Actual Study Start Date: Mar 1, 2020
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Motorized Spiral Enteroscopy Procedure: Motorized Spiral Enteroscopy: PowerSpiral enteroscope will be inserted and advanced with the assistance of motorized spiral rotation, After reaching the point of maximum insertion, cecum or if no further advancement of the enteroscope can be achieved, the enteroscope will be withdrawn using motorized counter-clockwise spiral rotation. When no total enteroscopy is reached, submucosal ink dye injection is performed as an endoscopically visible marker of the maximum insertion depth. A retrograde enteroscopy is then performed in the same session or at second session

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

Outcome Measures

Primary Outcome Measures

1. The diagnostic yield of motorized spiral enteroscopy [2 days]

   Diagnostic yield achieved by antegrade and/or retrograde enteroscopy using motorized spiral enteroscopy

2. The therapeutic yield of motorized spiral enteroscopy [2 days]

   Total number of therapeutic interventions performed during antegrade and/or retrograde enteroscopy using the motorized spiral enteroscopy

Secondary Outcome Measures

1. Total enteroscopy rate [2 days]

   Estimate the number of total enteroscopy procedures achieved by either antegrade only or antegrade and retrograde motorized spiral enteroscopy

2. Technical success [2 days]

   Estimate the rate of technically successful enteroscopy procedures both antegrade and retrograde motorized spiral enteroscopy

3. Total procedural time [2 days]

   The total time needed to complete the whole procedure of enteroscopy antegrade and/or retrograde motorized spiral enteroscopy

4. Depth of maximum insertion into the small bowel [2 days]

   Estimation of the maximum depth of insertion (in centimeters) both antegrade and/or retrograde motorized spiral enteroscopy

5. Adverse events [7 days]

   Total minor and also serious adverse events during and after antegrade and/or retrograde motorized spiral enteroscopy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	St Antonius hospital	Utrecht		Netherlands	3430 EM

Sponsors and Collaborators

• St. Antonius Hospital

Investigators

• Principal Investigator: A Al-Toma, Ph.D., St. Antonius Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abdulbaqi Al-Toma, Principal investigator, St. Antonius Hospital
• ClinicalTrials.gov Identifier: NCT04884113
• Other Study ID Numbers: W20.204
• First Posted: May 12, 2021
• Last Update Posted: Feb 7, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Abdulbaqi Al-Toma, Principal investigator, St. Antonius Hospital: Motorized Spiral enteroscopy; Device-assisted enteroscopy
• Additional relevant MeSH terms: Intestinal Diseases

Study Results

No Results Posted as of Feb 7, 2022