Small Bowel DiseaseNCT04884113
PowerSpiral Enteroscopy Performance and Safety
An observational study of Small Bowel Disease, run by St. Antonius Hospital at 5 sites in Netherlands.
Trial summary
Multicenter study to evaluate the efficacy of the motorized spiral enteroscope in the management of small bowel diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Bowel Disease
- What is being tested?
- Motorized Spiral enteroscopy
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 170 participants
- Where
- 5 sitesNetherlands
- Study dates
- 1 Mar 2020to 1 Mar 2022
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with suspected small bowel pathology indicated for diagnostic and/or therapeutic enteroscopy based on clinical presentation, small bowel imaging, or video capsule enteroscopy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Netherlands5 sites
VU University Medical Center
Amsterdam, 6813KJ
University Medical Centre Groningen
Groningen, 9700 RB
Leiden University Medical Centre
Leiden, 2311ZN
Maastricht UMC+
Maastricht, 6202 AZ
St Antonius hospital
Utrecht, 3430 EM
About this study
Official title: PowerSpiral Enteroscopy: Multicenter Prospective Study on Performance and Safety Including Patients With Altered Gastrointestinal Anatomy
Multicenter study to evaluate the efficacy of the motorized spiral enteroscope in the management of small bowel diseases.
Read the 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.
- Conditions
- Small Bowel Disease
- Being tested
- Motorized Spiral enteroscopy
- Keywords
- Motorized Spiral enteroscopy, Device-assisted enteroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motorized Spiral enteroscopyDevice
Small-bowel enteroscopy for diagnosis and intervention
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Motorized Spiral enteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic yield of motorized spiral enteroscopy
Diagnostic yield achieved by antegrade and/or retrograde enteroscopy using motorized spiral enteroscopy
Measured: 2 days
The therapeutic yield of motorized spiral enteroscopy
Total number of therapeutic interventions performed during antegrade and/or retrograde enteroscopy using the motorized spiral enteroscopy
Measured: 2 days
Secondary outcomes (5)
Total enteroscopy rate
Estimate the number of total enteroscopy procedures achieved by either antegrade only or antegrade and retrograde motorized spiral enteroscopy
Measured: 2 days
Technical success
Estimate the rate of technically successful enteroscopy procedures both antegrade and retrograde motorized spiral enteroscopy
Measured: 2 days
Total procedural time
The total time needed to complete the whole procedure of enteroscopy antegrade and/or retrograde motorized spiral enteroscopy
Measured: 2 days
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
Measured: 2 days
Adverse events
Total minor and also serious adverse events during and after antegrade and/or retrograde motorized spiral enteroscopy
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start1 Mar 2020
- Primary completion30 Dec 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Bowel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulbaqi Al-Toma, St. Antonius Hospital
- Investigators
- A Al-Toma, Ph.D., Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884113
- Sponsor's protocol ID
- W20.204
- Status last verified
- Apr 2023
- First submitted
- 3 May 2021
- Last updated
- 26 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Toma A, Beaumont H, Koornstra JJ, van Boeckel P, Hergelink DO, van der Kraan J, Inderson A, de Ridder R, Jacobs M. The performance and safety of motorized spiral enteroscopy, including in patients with surgically altered gastrointestinal anatomy: a multicenter prospective study. Endoscopy. 2022 Nov;54(11):1034-1042. doi: 10.1055/a-1783-4802. Epub 2022 Feb 28.
PubMed 35226945
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PowerSpiral Enteroscopy: Multicenter Prospective Study on Performance and Safety Including Patients With Altered Gastrointestinal Anatomy
- ClinicalTrials.gov ID
- NCT04884113
- Acronym / sponsor ID
- W20.204
- Conditions
- Small Bowel Disease
- Keywords
- Motorized Spiral enteroscopy, Device-assisted enteroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Motorized Spiral Enteroscopy | – | Device: Motorized Spiral enteroscopyProcedure: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected small bowel pathology indicated for diagnostic and/or therapeutic enteroscopy based on clinical presentation, small bowel imaging, or video capsule enteroscopy
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motorized Spiral enteroscopySmall-bowel enteroscopy for diagnosis and intervention | Device | Experimental: Motorized Spiral Enteroscopy |
Primary outcome
The diagnostic yield of motorized spiral enteroscopy
Time frame: 2 days
Diagnostic yield achieved by antegrade and/or retrograde enteroscopy using motorized spiral enteroscopy
The therapeutic yield of motorized spiral enteroscopy
Time frame: 2 days
Total number of therapeutic interventions performed during antegrade and/or retrograde enteroscopy using the motorized spiral enteroscopy
5 secondary outcomes
Total enteroscopy rate
Time frame: 2 days
Technical success
Time frame: 2 days
Total procedural time
Time frame: 2 days
Depth of maximum insertion into the small bowel
Time frame: 2 days
Adverse events
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Derived from this study: PubMed 35226945Al-Toma A, Beaumont H, Koornstra JJ, van Boeckel P, Hergelink DO, van der Kraan J, Inderson A, de Ridder R, Jacobs M. The performance and safety of motorized spiral enteroscopy, including in patients with surgically altered gastrointestinal anatomy: a multicenter prospective study. Endoscopy. 2022 Nov;54(11):1034-1042. doi: 10.1055/a-1783-4802. Epub 2022 Feb 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A Al-Toma, Ph.D. principal investigator
St. Antonius Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Bowel Disease, run by St. Antonius Hospital at 5 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic yield of motorized spiral enteroscopy (time frame: 2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04884113, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.