Small Bowel DiseaseNCT06111131
Ancora-SB Overtube Complete Positioning and Optical Visualization During Endoscopic Procedures
A study testing Enteroscopy in people with Small Bowel Disease, run by Aspero Medical, Inc. at 5 sites in United States.
Trial summary
Demonstrate superiority of the Aspero Medical Ancora-SB balloon Overtube compared to the Olympus ST-SB1 Balloon Overtube. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Small Bowel Disease
- What is being tested?
- Enteroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 5 sitesUnited States
- Study dates
- 15 Jan 2024to 15 May 2025
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide informed consent;
- Subject meets the minimal safety criteria for single balloon enteroscopy: ASA Class I, II, or III;11
- ≥ 18 years of age to ≤ 90 years of age;
- Video capsule endoscopy identified lesions in the middle third of the small bowel;
- Willing and able to comply with all study procedures and follow-up.
Who cannot join
- History of gastric bypass or related procedures;
- History of foregut and/or midgut surgery;
- Pathology identified by video capsule is in the proximal 1/3 of the bowel;
- Pathology identified by video capsule is in the distal 1/3 of the bowel;
- Anticoagulant and antiplatelet therapy that cannot be stopped for the enteroscopy;
- Capsule endoscopy did not show clear visualization of pathology in the middle small bowel;
Show all 11Show fewer
- Inability to tolerate the investigator's method of sedation that is the standard of care;
- Any previous small bowel surgery, or anastomosis, that caused extensive adhesions and/or altered anatomy;
- Allergy to any medications or product used in the endoscopic procedure where the severe allergic reaction cannot be prevented with pre-medication;
- Pregnancy;
- Life expectancy < six (6) months.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites, 5 recruiting
- Not yet recruiting
University of Maryland
Baltimore, Maryland, 21201
Andrew Canakis, 410-328-1895, ACanakis@som.umaryland.edu
- Not yet recruiting
Johns Hopkins
Baltimore, Maryland, 21205
Lisa Datta, lisadatta@jhmi.edu
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Luke Roberts, 614-293-6255, Luke.Roberts@osumc.edu
- Not yet recruiting
Cedars Sinai
Los Angeles, California, 90048
Claudia Bancila, 310-423-3872, Liliana.Bancila@cshs.org
- Not yet recruiting
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110
Thomas Hollander, RN, 314-747-1973, hollandert@wustl.edu
About this study
Official title: A Randomized Controlled Trial to Demonstrate the Ancora-SB Overtube Complete Positioning and Optical Visualization During Endoscopic Procedures for Diagnosis and Treatment in the Small Intestine
Demonstrate superiority of the Aspero Medical Ancora-SB balloon Overtube compared to the Olympus ST-SB1 Balloon Overtube.
Read the detailed description
The study objective, demonstrate superiority of the Aspero Ancora-SB balloon overtube compared to the Olympus ST-SB1 Balloon Overtube, is necessary for adoption by clinicians. Broad adoption is expected to improve procedure success rates, reduce time to diagnosis or treatment (thereby, improving patient outcomes), and reduce the burden and costs of care for patients, providers, and insurers. Investigators propose to recruit patients scheduled for enteroscopy and use capsule endoscopy to identify patients with lesions in the middle third of the small bowel. The primary outcome of interest is success in identifying the lesion, which indicates sufficient balloon control to reach and visualize the site.
- Conditions
- Small Bowel Disease
- Being tested
- Enteroscopy
- Keywords
- Small Intestine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnteroscopyDevice
A procedure that uses a specially equipped endoscope to examine the small intestine lining. An enteroscopy uses an endoscope, a tube with a light and camera on the end and the endoscope, in the case of this study, is equipped with a single balloon overtube to advance the scope deeper into the small intestine, to reach the middle third of the small bowel.
| Study group | Role | What they receive |
|---|---|---|
| Ancora-SB Overtube | Active comparator | Enteroscopy with Ancora-SB Balloon Overtube Receives: Device: Enteroscopy |
| Olympus ST-SB1 Overtube | Active comparator | Enteroscopy with Olympus ST-SB1 Overtube Receives: Device: Enteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Superiority
Demonstrate superiority of the Aspero Medical Ancora-SB balloon Overtube compared to the Olympus ST-SB1 Balloon Overtube. Superiority of the Ancora-SB Balloon Overtube will be demonstrated if it achieves a success rate of ≥75% compared to a success rate of 50% with the Olympus ST-SB1 Balloon Overtube.
Measured: Enteroscopy Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start15 Jan 2024
- Primary completion15 Mar 2025 (estimated)
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double-blind randomized 1:1 controlled post-market study; the investigator and the subject will be blind to the device. A qualified staff member will assist the endoscopist by performing the preparation, insertion, and removal of the device the subject was randomized to, to ensure the investigator is blinded. The shaft and handle end of the Ancora-SB overtube will be the same as the Olympus ST-SB1 overtube.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aspero Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111131
- Sponsor's protocol ID
- ASPE-CLIN-2022-01
- Status last verified
- Apr 2024
- First submitted
- 26 Oct 2023
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Demonstrate the Ancora-SB Overtube Complete Positioning and Optical Visualization During Endoscopic Procedures for Diagnosis and Treatment in the Small Intestine
- ClinicalTrials.gov ID
- NCT06111131
- Acronym / sponsor ID
- ASPE-CLIN-2022-01
- Conditions
- Small Bowel Disease
- Keywords
- Small Intestine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- Aspero Medical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 1 Nov 2023 (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.
Demonstrate superiority of the Aspero Medical Ancora-SB balloon Overtube compared to the Olympus ST-SB1 Balloon Overtube.
Detailed description
The study objective, demonstrate superiority of the Aspero Ancora-SB balloon overtube compared to the Olympus ST-SB1 Balloon Overtube, is necessary for adoption by clinicians. Broad adoption is expected to improve procedure success rates, reduce time to diagnosis or treatment (thereby, improving patient outcomes), and reduce the burden and costs of care for patients, providers, and insurers. Investigators propose to recruit patients scheduled for enteroscopy and use capsule endoscopy to identify patients with lesions in the middle third of the small bowel. The primary outcome of interest is success in identifying the lesion, which indicates sufficient balloon control to reach and visualize the site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a double-blind randomized 1:1 controlled post-market study; the investigator and the subject will be blind to the device. A qualified staff member will assist the endoscopist by performing the preparation, insertion, and removal of the device the subject was randomized to, to ensure the investigator is blinded. The shaft and handle end of the Ancora-SB overtube will be the same as the Olympus ST-SB1 overtube.
| Arm | Type | Receives |
|---|---|---|
| Ancora-SB Overtube | Active comparator | Device: EnteroscopyEnteroscopy with Ancora-SB Balloon Overtube |
| Olympus ST-SB1 Overtube | Active comparator | Device: EnteroscopyEnteroscopy with Olympus ST-SB1 Overtube |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Willing and able to provide informed consent;
- Subject meets the minimal safety criteria for single balloon enteroscopy: ASA Class I, II, or III;11
- ≥ 18 years of age to ≤ 90 years of age;
- Video capsule endoscopy identified lesions in the middle third of the small bowel;
- Willing and able to comply with all study procedures and follow-up.
Key exclusion criteria (11 listed)
- History of gastric bypass or related procedures;
- History of foregut and/or midgut surgery;
- Pathology identified by video capsule is in the proximal 1/3 of the bowel;
- Pathology identified by video capsule is in the distal 1/3 of the bowel;
- Anticoagulant and antiplatelet therapy that cannot be stopped for the enteroscopy;
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 |
|---|---|---|
| EnteroscopyA procedure that uses a specially equipped endoscope to examine the small intestine lining. An enteroscopy uses an endoscope, a tube with a light and camera on the end and the endoscope, in the case of this study, is equipped with a single balloon overtube to advance the scope deeper into the small intestine, to reach the middle third of the small bowel. | Device | Ancora-SB Overtube, Olympus ST-SB1 Overtube |
Primary outcome
Device Superiority
Time frame: Enteroscopy Procedure
Demonstrate superiority of the Aspero Medical Ancora-SB balloon Overtube compared to the Olympus ST-SB1 Balloon Overtube. Superiority of the Ancora-SB Balloon Overtube will be demonstrated if it achieves a success rate of ≥75% compared to a success rate of 50% with the Olympus ST-SB1 Balloon Overtube.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enteroscopy in people with Small Bowel Disease, run by Aspero Medical, Inc. at 5 sites 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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 19 Apr 2024. 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 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?
Contact Chris Schultz, BS (9715067552, cschultz@ecr-inc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Superiority (time frame: Enteroscopy Procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2024.