ColonoscopyNCT05626738
Endorail in Long Lasting Colonoscopy
A study testing ENDORAIL in people with Colonoscopy and Incomplete Colonoscopy, run by Endostart srl at 3 sites in 3 countries.
Trial summary
Patients with long lasting colonoscopy are characterized by higher risk of incompletion. Endorail is an accessory for colonoscopy aimed at facilitating progression of the endoscope in the large intestine. Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Colonoscopy, Incomplete Colonoscopy
- What is being tested?
- ENDORAIL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 25 Jan 2023to 24 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes aged between 22 - 75 years (inclusive);
- Outpatients undergoing long-lasting diagnostic and surveillance colonoscopy; long-lasting colonoscopy is defined as follows: colonoscopy completion (caecal intubation) not achieved after 10 minutes from endoscope insertion through the anal canal;
- Patients have given a written informed consent for participation in the study at the time of enrolment or before;
- Patients able to understand the full nature and the purpose of the investigation, including possible risks and side effects, able to cooperate with the Investigator and to comply with the requirements of the entire investigation based on Investigator's judgement.
Who cannot join
- Body mass index (BMI) > 30 kg/m2;
- Outpatients undergoing colonoscopy for colorectal cancer screening or therapeutic indication;
- Patients in class >2 physical status of the classification system of American Society of Anaesthesiologists;
- Any contraindications to colonoscopy;
- Any contraindications to sedation;
- Known allergy or hypersensitivity to any of the elements of the Endorail Set (e.g.: iron);
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- Patients with permanently or semi-permanently implanted medical devices, (e.g. orthopedic implants, trauma fixation devices, cardiac pacemakers, implantable cardioverter defibrillator, drug pumps, neurostimulators, vascular stents, cochlear implants, aneurysm clip);
- Presence of dense diverticulosis
- Presence of diverticulitis
- Presence of ferromagnetic foreign body;
- Presence of large abdominal hernias;
- Presence of severe thrombocytopenia;
- Presence of severe granulocytopenia;
- Presence of severe coagulopathy;
- Presence of peritonitis;
- Presence of colonic wall ischemia or necrosis or injured mucosa;
- Presence of peritoneal carcinomatosis;
- Boston Bowel Preparation Scale <2 in at least one of the colonic segments;
- Presence of obstructing masses and strictures of the colon;
- History of total or subtotal colectomy.
- Presence of angulated and fixed colon curves;
- Pregnant or breast-feeding women;
- Patient unable to provide the signed informed consent, uncooperative patient or patient unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study;
- Presence of any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromises the subject safety
- Concomitant participation in other clinical investigations or participation in the evaluation of any investigational product/device in the 30 days before this study or previous participation in the same investigation;
- Urgent colonoscopy.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Multicenter Clinical Trial for the Evaluation of Safety and Effectiveness of Endorail in Patients With Long-lasting Colonoscopy
Patients with long lasting colonoscopy are characterized by higher risk of incompletion. Endorail is an accessory for colonoscopy aimed at facilitating progression of the endoscope in the large intestine. Endorail works as a magnetic anchor that is able to guide the colonoscope and to straighten colon curves and loops. The aim of this study is to test the safety and efficacy of Endorail in ensuring that incompletion rate in long-lasting colonoscopies is lower than the 10% threshold. Outpatients of either sex aged between 22-75 years undergoing elective diagnostic or surveillance colonoscopy with caecal intubation time greater than 10 minutes will take part in the study. The primary efficacy endpoint is the percentage minor or equal to 10% of incomplete long-lasting colonoscopies. The primary safety endpoints are the absence of device-related serious adverse events and the evaluation of the equality or reduction of the adverse events rates compared to diagnostic colonoscopies without Endorail.
Read the detailed description
Patients with long lasting colonoscopy are characterized by higher risk of incompletion. A colonoscopy can be defined as incomplete when the endoscopist cannot reach the caecum. Caecal intubation is one of the main goals of colonoscopy and represents a diagnostic quality indicator. International guidelines recommend caecal intubation rates ≥90% for all colonoscopies in daily clinical practice. Reported incomplete colonoscopy rates range from 4% to 25%. Caecal intubation fails in 4-10% of cases in tertiary referred centres, instead in national surveys colonoscopies are incomplete in 10-25% of cases.
Endorail is a medical device intended to facilitate the positioning of a standard colonoscope. Endorail is a colonoscopy add-on device that works as a magnetic anchor able to guide the colonoscope and to straighten colon curves and loops.
Endorail is composed by the following two CE marked medical devices: Endorail Set and Endorail System. Endorail Set consists of the Endorail Balloon Guide, The Endorail Solution Syringe, The Endorail Powder and the Spike. Endorail System consists of the Endorail Handpiece and the Endorail Cart.
The aim of this study is to test the safety and efficacy of the Endorail in ensuring that incompletion rate in long-lasting colonoscopies is lower than the 10% threshold.
Outpatients of either sex aged between 22-75 years, undergoing elective colonoscopy for diagnostic or surveillance colonoscopy, who have signed a written informed consent and presenting caecal intubation time greater than 10 minutes, will take part in the study. The study plan will include a screening/baseline/treatment visit (Visit 1/Day 1), during which colonoscopy with the investigational medical device Endorail will be performed and a phone follow-up visit (Visit 2), scheduled at 7 (± 1) day after treatment with the investigational medical device Endorail.
The primary efficacy endpoint is the percentage minor or equal to 10% of incomplete long-lasting colonoscopies
The primary safety endpoints are:
- The absence of device-related serious adverse events. AND
- The evaluation of the equality or reduction of the adverse events rates compared to diagnostic colonoscopies without Endorail.
- Conditions
- Colonoscopy, Incomplete Colonoscopy
- Being tested
- ENDORAIL
- Keywords
- Medical Device, Colonoscopy, Gastrointestinal endoscopy, Magnetic Balloon Technology, Looping, Safety, Effectiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENDORAILDevice
Also called Endorail Set - Endorail System
In case caecal intubation time is longer than 10 minutes, the balloon catheter is inserted in the tool channel, advanced beyond the colonoscope tip and filled with Ferromagnetic Fluid. By applying the Endorail Handpiece over the patient abdomen, the balloon can be magnetically anchored. The anchored balloon guide allows to straighten the scope and the colon itself. The colonoscope can thus be easily moved back and forward along the anchored guide to facilitate colonoscope positioning and colonoscopy completion. Afterward, Endorail is removed and the straightened colonoscope can be easily pushed forward to achieve colonoscopy completion according to standard endoscopic technique.
| Study group | Role | What they receive |
|---|---|---|
| Long-lasting Colonoscopy With Endorail | Experimental | In case of long-lasting colonoscopy, Endorail is used to facilitate the completion of the procedure. Receives: Device: ENDORAIL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Incomplete Long-lasting Colonscopies
Colonoscopy is defined completed when caecal intubation is achieved. Colonoscopy is defined long-lasting when caecal intubation time is longer than 10 minutes. The percentage of incomplete long-lasting colonscopies is calculated as the ratio, in percetange, between the number of incomplete long-lasting colonscopies and the total number of patients enrolled.
Measured: day 1
Number of Device-related Serious Adverse Events
Number of the device-related serious adverse events collected at day 1 visit
Measured: day 1
Number of Device-related Serious Adverse Events
Number of device-related serious adverse events collected through phone call at day 7.
Measured: day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start25 Jan 2023
- Primary completion24 May 2023
- Study completion24 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ColonoscopyStudies 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
- Model description
- Multi Centre, Post Market, Single Arm, Open-Label, Interventional Study
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endostart srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alessandro F Ferri, Study director, Advice Pharma Group S.r.l.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626738
- Sponsor's protocol ID
- Endorail
- Status last verified
- Apr 2024
- First submitted
- 8 Nov 2022
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Clinical Trial for the Evaluation of Safety and Effectiveness of Endorail in Patients With Long-lasting Colonoscopy
- ClinicalTrials.gov ID
- NCT05626738
- Acronym / sponsor ID
- Endorail
- Conditions
- Colonoscopy, Incomplete Colonoscopy
- Keywords
- Medical Device, Colonoscopy, Gastrointestinal endoscopy, Magnetic Balloon Technology, Looping, Safety, Effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Endostart srlIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 24 May 2023 (actual)
- Study completion
- 24 Jul 2023 (actual)
- First posted
- 25 Nov 2022 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with long lasting colonoscopy are characterized by higher risk of incompletion. Endorail is an accessory for colonoscopy aimed at facilitating progression of the endoscope in the large intestine. Endorail works as a magnetic anchor that is able to guide the colonoscope and to straighten colon curves and loops. The aim of this study is to test the safety and efficacy of Endorail in ensuring that incompletion rate in long-lasting colonoscopies is lower than the 10% threshold. Outpatients of either sex aged between 22-75 years undergoing elective diagnostic or surveillance colonoscopy with caecal intubation time greater than 10 minutes will take part in the study. The primary efficacy endpoint is the percentage minor or equal to 10% of incomplete long-lasting colonoscopies. The primary safety endpoints are the absence of device-related serious adverse events and the evaluation of the equality or reduction of the adverse events rates compared to diagnostic colonoscopies without Endorail.
Detailed description
Patients with long lasting colonoscopy are characterized by higher risk of incompletion. A colonoscopy can be defined as incomplete when the endoscopist cannot reach the caecum. Caecal intubation is one of the main goals of colonoscopy and represents a diagnostic quality indicator. International guidelines recommend caecal intubation rates ≥90% for all colonoscopies in daily clinical practice. Reported incomplete colonoscopy rates range from 4% to 25%. Caecal intubation fails in 4-10% of cases in tertiary referred centres, instead in national surveys colonoscopies are incomplete in 10-25% of cases.
Endorail is a medical device intended to facilitate the positioning of a standard colonoscope. Endorail is a colonoscopy add-on device that works as a magnetic anchor able to guide the colonoscope and to straighten colon curves and loops.
Endorail is composed by the following two CE marked medical devices: Endorail Set and Endorail System. Endorail Set consists of the Endorail Balloon Guide, The Endorail Solution Syringe, The Endorail Powder and the Spike. Endorail System consists of the Endorail Handpiece and the Endorail Cart.
The aim of this study is to test the safety and efficacy of the Endorail in ensuring that incompletion rate in long-lasting colonoscopies is lower than the 10% threshold.
Outpatients of either sex aged between 22-75 years, undergoing elective colonoscopy for diagnostic or surveillance colonoscopy, who have signed a written informed consent and presenting caecal intubation time greater than 10 minutes, will take part in the study. The study plan will include a screening/baseline/treatment visit (Visit 1/Day 1), during which colonoscopy with the investigational medical device Endorail will be performed and a phone follow-up visit (Visit 2), scheduled at 7 (± 1) day after treatment with the investigational medical device Endorail.
The primary efficacy endpoint is the percentage minor or equal to 10% of incomplete long-lasting colonoscopies
The primary safety endpoints are:
- The absence of device-related serious adverse events. AND
- The evaluation of the equality or reduction of the adverse events rates compared to diagnostic colonoscopies without Endorail.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multi Centre, Post Market, Single Arm, Open-Label, Interventional Study
| Arm | Type | Receives |
|---|---|---|
| Long-lasting Colonoscopy With Endorail | Experimental | Device: ENDORAILIn case of long-lasting colonoscopy, Endorail is used to facilitate the completion of the procedure. |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of both sexes aged between 22 - 75 years (inclusive);
- Outpatients undergoing long-lasting diagnostic and surveillance colonoscopy; long-lasting colonoscopy is defined as follows: colonoscopy completion (caecal intubation) not achieved after 10 minutes from endoscope insertion through the anal canal;
- Patients have given a written informed consent for participation in the study at the time of enrolment or before;
- Patients able to understand the full nature and the purpose of the investigation, including possible risks and side effects, able to cooperate with the Investigator and to comply with the requirements of the entire investigation based on Investigator's judgement.
Key exclusion criteria (26 listed)
- Body mass index (BMI) > 30 kg/m2;
- Outpatients undergoing colonoscopy for colorectal cancer screening or therapeutic indication;
- Patients in class >2 physical status of the classification system of American Society of Anaesthesiologists;
- Any contraindications to colonoscopy;
- Any contraindications to sedation;
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 |
|---|---|---|
| ENDORAILAlso: Endorail Set - Endorail SystemIn case caecal intubation time is longer than 10 minutes, the balloon catheter is inserted in the tool channel, advanced beyond the colonoscope tip and filled with Ferromagnetic Fluid. By applying the Endorail Handpiece over the patient abdomen, the balloon can be magnetically anchored. The anchored balloon guide allows to straighten the scope and the colon itself. The colonoscope can thus be easily moved back and forward along the anchored guide to facilitate colonoscope positioning and colonoscopy completion. Afterward, Endorail is removed and the straightened colonoscope can be easily pushed forward to achieve colonoscopy completion according to standard endoscopic technique. | Device | Long-lasting Colonoscopy With Endorail |
Primary outcome
Percentage of Incomplete Long-lasting Colonscopies
Time frame: day 1
Colonoscopy is defined completed when caecal intubation is achieved. Colonoscopy is defined long-lasting when caecal intubation time is longer than 10 minutes. The percentage of incomplete long-lasting colonscopies is calculated as the ratio, in percetange, between the number of incomplete long-lasting colonscopies and the total number of patients enrolled.
Number of Device-related Serious Adverse Events
Time frame: day 1
Number of the device-related serious adverse events collected at day 1 visit
Number of Device-related Serious Adverse Events
Time frame: day 7
Number of device-related serious adverse events collected through phone call at day 7.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Alessandro F Ferri study director
Advice Pharma Group S.r.l.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENDORAIL in people with Colonoscopy and Incomplete Colonoscopy, run by Endostart srl at 3 sites in 3 countries.
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 4 inclusion and 26 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Germany, Italy. 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?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Incomplete Long-lasting Colonscopies (time frame: day 1). The study lists 3 primary outcomes in all. 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 Sep 2024.