Small Bowel DiseaseNCT03990207
The PowerSpiral Antegrade Investigational Device Exemption (IDE) Study
A study testing PowerSpiral Enteroscopy System in people with Small Bowel Disease, run by Olympus Corporation of the Americas at 1 site in United States.
Trial summary
To evaluate safety and efficacy Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Small Bowel Disease
- What is being tested?
- PowerSpiral Enteroscopy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2022to Oct 2023
- Phase
- Interventional
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is ≥ 22 years of age
- Medical indication for antegrade enteroscopy
- Willing and able to provide informed consent
Who cannot join
- Any medical contraindication to standard enteroscopy
- Any test that is done as part of the standard of care that would prevent the enteroscopy from being performed for safety reasons
- Unable or unwilling to provide informed consent
- Female and of child-bearing age who is currently pregnant or planning to become pregnant within the study period
- Presence of any intra-luminal or extra-luminal foreign body in the abdominal cavity
- Any prior gastric, small bowel or colonic surgery, or implantable devices in these locations (cardiac pacemakers and non-abdominal implants are acceptable)
Show all 17Show fewer
- Known or suspected bowel obstruction, or history of bowel obstruction
- Taking anti-platelet agents or anticoagulants (other than aspirin) within last 7 days
- Known coagulation disorder
- Known or suspected esophageal stricture or Schatzki ring
- Known gastric or esophageal varices
- Suspected perforation of the gastrointestinal (GI) tract
- Previous abdominal radiation
- Inability to tolerate general anesthesia for any reason
- Inability to tolerate endotracheal intubation
- Known need for endoscopic retrograde cholangiopancreatography (ERCP) during enteroscopy
- American Society of Anesthesiologists (ASA) Classification 4 or greater
Trial locations and contacts
1 site in 1 country.
United States1 site
Olympus Corporation of the Americas
Southborough, Massachusetts, 01772
About this study
Official title: A Prospective, Multicenter, Single-Arm, Pre-Market, Pivotal Study to Evaluate Safety and Efficacy of a Novel Motorized Spiral Enteroscope for Antegrade Enteroscopy
To evaluate safety and efficacy
Read the detailed description
The purpose of this study is to evaluate the safety and efficacy of the PowerSpiral™ Enteroscopy System, when used in subjects undergoing antegrade (per-oral) enteroscopy of the small bowel.
- Conditions
- Small Bowel Disease
- Being tested
- PowerSpiral Enteroscopy System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PowerSpiral Enteroscopy SystemDevice
Motorized spiral enteroscopy system
| Study group | Role | What they receive |
|---|---|---|
| PowerSpiral Enteroscopy System | Experimental | Subjects who have a medical indication for antegrade enteroscopy Receives: Device: PowerSpiral Enteroscopy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of device related serious adverse events
The primary safety endpoint will compare the rate of device related serious adverse events (SAE) reported in this study to the rate of device related SAEs reported in medical literature for the Spirus Medical Endo-Ease Discovery™ SB overtube
Measured: 7 days
Maximum depth of endoscope insertion
The primary efficacy endpoint will compare the maximum depth of enteroscope insertion for the study device to the maximum depth of enteroscope insertion data reported in medical literature for the Spirus Medical Endo-Ease Discovery™ SB overtube.
Measured: Intraoperative
Secondary outcomes (7)
Total procedure time
Measured from initial enteroscope introduction through the bite block to final enteroscope withdrawal through the bite block in minutes.
Measured: Intraoperative
Insertion time
Measured from the initial enteroscope introduction through the bite block to maximum depth of enteroscope insertion measured in minutes
Measured: Intraoperative
Withdrawn time
Measured from maximum depth of enteroscope insertion excluding any time spent on therapeutic interventions, to final enteroscope withdrawal through bite block measured in minutes.
Measured: Intraoperative
Total enteroscopy rate
Percentage of subjects where the entire small intestine is intubated with the enteroscopy from pylorus to cecum.
Measured: Intraoperative
Diagnostic yield
Percentage of subjects where enteroscopy produces the findings required to establish diagnosis.
Measured: Intraoperative
Adverse events
SAEs regardless of relationship to study device and/or procedure, and non-SAEs related to study device and/or procedure
Measured: 7 days post-procedure
Device deficiencies
Number of device deficiencies during the enteroscopy procedure
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study startAug 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionOct 2023 (estimated)
Why it stopped: Not moving forward with the study at this time. No subject were consented or enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olympus Corporation of the Americas
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baylor Research Institute, University of Massachusetts, Worcester, University of Florida, AdventHealth, Rhode Island Hospital
- Responsible party
- Sponsor
- Investigators
- Daniel DeMarco, MD, Principal investigator, Baylor Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990207
- Sponsor's protocol ID
- 2018-OCA-01
- Status last verified
- Aug 2022
- First submitted
- 11 Jun 2019
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Baniya R, Upadhaya S, Subedi SC, Khan J, Sharma P, Mohammed TS, Bachuwa G, Jamil LH. Balloon enteroscopy versus spiral enteroscopy for small-bowel disorders: a systematic review and meta-analysis. Gastrointest Endosc. 2017 Dec;86(6):997-1005. doi: 10.1016/j.gie.2017.06.015. Epub 2017 Jun 23.
PubMed 28652176Buscaglia JM, Richards R, Wilkinson MN, Judah JR, Lam Y, Nagula S, Draganov PV. Diagnostic yield of spiral enteroscopy when performed for the evaluation of abnormal capsule endoscopy findings. J Clin Gastroenterol. 2011 Apr;45(4):342-6. doi: 10.1097/MCG.0b013e3181eeb74b.
PubMed 20861800Khashab MA, Lennon AM, Dunbar KB, Singh VK, Chandrasekhara V, Giday S, Canto MI, Buscaglia JM, Kapoor S, Shin EJ, Kalloo AN, Okolo PI 3rd. A comparative evaluation of single-balloon enteroscopy and spiral enteroscopy for patients with mid-gut disorders. Gastrointest Endosc. 2010 Oct;72(4):766-72. doi: 10.1016/j.gie.2010.04.043. Epub 2010 Jul 8.
PubMed 20619404Akerman PA, Haniff M. Spiral enteroscopy: prime time or for the happy few? Best Pract Res Clin Gastroenterol. 2012 Jun;26(3):293-301. doi: 10.1016/j.bpg.2012.03.008.
PubMed 22704571
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-Arm, Pre-Market, Pivotal Study to Evaluate Safety and Efficacy of a Novel Motorized Spiral Enteroscope for Antegrade Enteroscopy
- ClinicalTrials.gov ID
- NCT03990207
- Acronym / sponsor ID
- 2018-OCA-01
- Conditions
- Small Bowel Disease
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Not moving forward with the study at this time. No subject were consented or enrolled
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Olympus Corporation of the AmericasIndustry (pharma, biotech, devices)
- Collaborators
- Baylor Research Institute, University of Massachusetts, Worcester, University of Florida, AdventHealth, Rhode Island Hospital
- Study start
- Aug 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 18 Jun 2019 (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.
To evaluate safety and efficacy
Detailed description
The purpose of this study is to evaluate the safety and efficacy of the PowerSpiral™ Enteroscopy System, when used in subjects undergoing antegrade (per-oral) enteroscopy of the small bowel.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PowerSpiral Enteroscopy System | Experimental | Device: PowerSpiral Enteroscopy SystemSubjects who have a medical indication for antegrade enteroscopy |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is ≥ 22 years of age
- Medical indication for antegrade enteroscopy
- Willing and able to provide informed consent
Key exclusion criteria (17 listed)
- Any medical contraindication to standard enteroscopy
- Any test that is done as part of the standard of care that would prevent the enteroscopy from being performed for safety reasons
- Unable or unwilling to provide informed consent
- Female and of child-bearing age who is currently pregnant or planning to become pregnant within the study period
- Presence of any intra-luminal or extra-luminal foreign body in the abdominal cavity
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 |
|---|---|---|
| PowerSpiral Enteroscopy SystemMotorized spiral enteroscopy system | Device | PowerSpiral Enteroscopy System |
Primary outcome
Rate of device related serious adverse events
Time frame: 7 days
The primary safety endpoint will compare the rate of device related serious adverse events (SAE) reported in this study to the rate of device related SAEs reported in medical literature for the Spirus Medical Endo-Ease Discovery™ SB overtube
Maximum depth of endoscope insertion
Time frame: Intraoperative
The primary efficacy endpoint will compare the maximum depth of enteroscope insertion for the study device to the maximum depth of enteroscope insertion data reported in medical literature for the Spirus Medical Endo-Ease Discovery™ SB overtube.
7 secondary outcomes
Total procedure time
Time frame: Intraoperative
Insertion time
Time frame: Intraoperative
Withdrawn time
Time frame: Intraoperative
Total enteroscopy rate
Time frame: Intraoperative
Diagnostic yield
Time frame: Intraoperative
Adverse events
Time frame: 7 days post-procedure
Device deficiencies
Time frame: Intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Background: PubMed 28652176Baniya R, Upadhaya S, Subedi SC, Khan J, Sharma P, Mohammed TS, Bachuwa G, Jamil LH. Balloon enteroscopy versus spiral enteroscopy for small-bowel disorders: a systematic review and meta-analysis. Gastrointest Endosc. 2017 Dec;86(6):997-1005. doi: 10.1016/j.gie.2017.06.015. Epub 2017 Jun 23.
- Background: PubMed 20861800Buscaglia JM, Richards R, Wilkinson MN, Judah JR, Lam Y, Nagula S, Draganov PV. Diagnostic yield of spiral enteroscopy when performed for the evaluation of abnormal capsule endoscopy findings. J Clin Gastroenterol. 2011 Apr;45(4):342-6. doi: 10.1097/MCG.0b013e3181eeb74b.
- Background: PubMed 20619404Khashab MA, Lennon AM, Dunbar KB, Singh VK, Chandrasekhara V, Giday S, Canto MI, Buscaglia JM, Kapoor S, Shin EJ, Kalloo AN, Okolo PI 3rd. A comparative evaluation of single-balloon enteroscopy and spiral enteroscopy for patients with mid-gut disorders. Gastrointest Endosc. 2010 Oct;72(4):766-72. doi: 10.1016/j.gie.2010.04.043. Epub 2010 Jul 8.
- Background: PubMed 22704571Akerman PA, Haniff M. Spiral enteroscopy: prime time or for the happy few? Best Pract Res Clin Gastroenterol. 2012 Jun;26(3):293-301. doi: 10.1016/j.bpg.2012.03.008.
- Individual participant dataSharing planned: Undecided
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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.
Daniel DeMarco, MD principal investigator
Baylor Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PowerSpiral Enteroscopy System in people with Small Bowel Disease, run by Olympus Corporation of the Americas at 1 site in United States.
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 17 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: paused, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Results are not available in the source record.
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?
Rate of device related serious adverse events (time frame: 7 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 NCT03990207, which also lists 4 linked publications.
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 5 Aug 2022.