Polyp of ColonNCT04203667
EndoRotor® Endoscopic Mucosal Resection System for the Colon
A study testing EndoRotor Resection in people with Polyp of Colon and Endoscopic Mucosal Resection, run by Interscope, Inc. at 11 sites in 4 countries.
Trial summary
The EndoRotor® is intended for use (USA labeling) in endoscopic procedures by a trained gastroenterologist to resect and remove tissue, not intended for biopsy, of the gastrointestinal (GI) system including post-endoscopic mucosal resection (EMR) tissue persistence with a scarred base and residual tissue from the… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Polyp of Colon, Endoscopic Mucosal Resection, Recurrent Colon Adenoma
- What is being tested?
- EndoRotor Resection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 18 Apr 2018to 5 Apr 2020
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged ≥18 to ≤85 years.
- At least one recurrent flat or sessile colorectal lesion measuring up to 6 cm in diameter and/or length.
- Presence of recurrent flat or sessile lesion where the EndoRotor may be used to resect recurrent neoplasia.
- Favorable anatomy that allows the investigator to access the lesion.
- Subject is able and willing to comply with site standard medical follow-up, including the 90-day follow-up visit.
- Subject has been informed of the nature of the study, agrees to participate and has signed the consent form.
Who cannot join
- Inability to give informed consent.
- Subject age is <18 years of age or >85 years of age.
- Presence of a lesion that represents cancer or has a high chance of harboring submucosal invasive cancer.
- Presence of synchronous lesions intended for resection that would require use of a concomitant resection modality
- Medical reasons the procedure cannot be performed (i.e. labile blood pressure, anticoagulation laboratory levels that are too high and risk excessive bleeding, systemic infection, etc.)
- Active antiplatelet therapy (Plavix , 325mg aspirin therapy) - patient off treatment for < 1 week.
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- Inability to undergo a procedure under propofol sedation or General Anesthesia.
- Female patients who are known to be pregnant.
- Co-morbid conditions that place the subject at an unacceptable surgical risk (e.g., severe chronic obstructive pulmonary disease, hepatic failure, cardiac disease, autoimmune disorders or conditions of severe immunosuppression).
- Any clinical evidence that the investigator feels would place the subject at increased risk with the deployment of the device.
- Subject is participating in another study of a device, medication, biologic, or other agent within 90 days and could, in the opinion of the investigator, impact the results of this study.
- Subject has other medical, social or psychological problems that in the opinion of the investigator would preclude them from receiving this treatment and the procedures and participating in evaluations pre- and post-treatment.
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
Germany4 sites
Allgemeines Krankenhaus Celle
Celle, 29223
Clinic and Polyclinic for Interdisciplinary Endoscopy University Hospital Hamburg Eppendorf
Hamburg
Catholic Clinic Mainz
Mainz
Sana Klinikum Offenbach
Offenbach, 63069
France3 sites
Centre Hospitalier Universitaire (CHU)
Angers
Hopital Edouard Herriot
Lyon, 69003
Cochin University Hospital
Paris, 75014
Italy3 sites
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, 25124
Università Cattolica del Sacro Cuore, Instituto di Clinica Chirurgica
Rome, 00168
Humanitas Research Hospital & Humanitas University
Rozzano, 20089
United States1 site
Geisinger Medical Center
Danville, Pennsylvania, 17822
About this study
Official title: Prospective, Multicenter Study for the Evaluation of Safety and Performance of the Interscope EndoRotor Endoscopic Mucosal Resection System for the Removal of Alimentary Tract Mucosa in the Colon
The EndoRotor® is intended for use (USA labeling) in endoscopic procedures by a trained gastroenterologist to resect and remove tissue, not intended for biopsy, of the gastrointestinal (GI) system including post-endoscopic mucosal resection (EMR) tissue persistence with a scarred base and residual tissue from the peripheral margins following EMR.
In this trial investigators will conduct a post-market, prospective, non-randomized, multi-center study for the treatment of subjects with the need for resection of recurrent flat or sessile colorectal lesions where EndoRotor is the primary resection modality of persistent adenoma with a scarred base.
Read the detailed description
Although the majority of polyps are non-malignant, it is known that the risk of malignancy increases with polyp size, with polyps < 10 mm having < 1% risk of cancer, polyps of 10 mm having a 10% risk of cancer and polyps of 20 mm having a greater than 10% risk of cancer. It is also understood that a polyp of < 1 cm takes approximately 10 years to transform into invasive colorectal carcinoma. Therefore, adenomas greater than 5 mm are normally treated. Polyps with tethered bases resulting from scarring are often the most challenging to resect endoscopically. The scarring can be caused by previous attempts at resection, previous deep biopsies, or tattoos placed too closely. These polyps often do not lift and can be impossible to snare even when stiff snares are used. Endoscopic submucosal dissection (ESD) and knife-assisted resection (KAR) are techniques that have been shown effective in the management of scarred polyps, however these techniques have not been widely adopted in the West. Argon plasma coagulation has been more commonly used to ablate adenomatous tissue in scarred polyps but this technique does not allow for the histological assessment of the scarred polyp and is less effective than ESD. The EndoRotor provides a technique whereby the lesion can be effectively removed without adjunct procedures with collection of tissue for histological assessment.
- Being tested
- EndoRotor Resection
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoRotor ResectionDevice
The EndoRotor® is a powered cutting cannula for the removal of alimentary tract mucosa. Cutting is performed by aspirating tissue into a rotating cutting window. The resected tissue is immediately aspirated away from the resection site and collected in the EndoRotor Specimen Trap. The tissue can then be sent for pathological examination using standard methods.
The system consists of a power console, foot control, specimen trap with pre-loaded filter and the applied part, which is the single-use catheter.
| Study group | Role | What they receive |
|---|---|---|
| EndoRotor Resection Arm | Other | All participants enrolled in this study will undergo treatment with the EndoRotor during colonoscopy for endoscopic mucosal resection in the colon to resect and remove tissue, not intended for biopsy, of the gastrointestinal system including post-endoscopic endoscopic mucosal resection of tissue persistence with a scarred base and residual tissue from peripheral margins following endoscopic mucosal resection. Receives: Device: EndoRotor Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint Defined as the Ability of the EndoRotor to Resect Lesions Without Concomitant Use of Other Resection Modalities and With no Device-related Serious Adverse Events Through the 90 Day Post Procedure Follow-up Visit.
Measured: Index Procedure through 90 Day Post Procedure Follow-up Visit
Primary Safety Analysis Defined as the Occurrence of Serious Adverse Events Related to the EndoRotor Device as Measured From the Index Procedure Through the 90 Day Post Procedure Follow-up Visit.
Measured: Index Procedure through 90 Day Post Procedure Follow-up Visit
Secondary outcomes (4)
Efficacy Defined as the Number of Participants Where EndoRotor Was Able to Resect the Entire Lesion in a Single Procedure.
Measured: Index Procedure
Post-resection Stenosis Defined as the Occurrence of Colon Stenosis Following the Index Procedure.
Measured: 90-day follow-up visit
Rate of Disease Persistence Defined as Remnant Disease at the Location of the Index Resection as Determined Endoscopically by the Investigator at the 90 Day Follow-up Visit.
Measured: 90-day follow-up visit
Histologic Assessment Defined as the the Diagnostic Value of the Specimens Collected in the EndoRotor Specimen Trap (Could a Diagnosis be Rendered).
Measured: 90-day follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start18 Apr 2018
- Primary completion5 Apr 2020
- Study completion5 Apr 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polyp of ColonStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Post-market, prospective, non-randomized, multi-center study for the treatment of subjects with the need for resection of recurrent flat or sessile colorectal lesions where EndoRotor is the primary resection modality of persistent adenoma with a scarred base.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Interscope, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guido Costamagna, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203667
- Sponsor's protocol ID
- CLIN-0001
- Status last verified
- Apr 2022
- First submitted
- 16 Dec 2019
- Last updated
- 5 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Knabe M, Maselli R, Cesbron-Metivier E, Hollerbach S, Petruzziello L, Prat F, Khara HS, Pioche M, Hartmann D, Cesaro P, Barbaro F, Berger A, Spada C, Diehl DL, May A, Ponchon T, Repici A, Costamagna G. Endoscopic powered resection device for residual colonic lesions: the first multicenter, prospective, international clinical study. Gastrointest Endosc. 2024 May;99(5):778-786. doi: 10.1016/j.gie.2023.11.050. Epub 2023 Dec 1.
PubMed 38042207
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter Study for the Evaluation of Safety and Performance of the Interscope EndoRotor Endoscopic Mucosal Resection System for the Removal of Alimentary Tract Mucosa in the Colon
- ClinicalTrials.gov ID
- NCT04203667
- Acronym / sponsor ID
- CLIN-0001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Interscope, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 5 Apr 2020 (actual)
- Study completion
- 5 Apr 2020 (actual)
- First posted
- 18 Dec 2019 (actual)
- Results
- Posted 5 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The EndoRotor® is intended for use (USA labeling) in endoscopic procedures by a trained gastroenterologist to resect and remove tissue, not intended for biopsy, of the gastrointestinal (GI) system including post-endoscopic mucosal resection (EMR) tissue persistence with a scarred base and residual tissue from the peripheral margins following EMR.
In this trial investigators will conduct a post-market, prospective, non-randomized, multi-center study for the treatment of subjects with the need for resection of recurrent flat or sessile colorectal lesions where EndoRotor is the primary resection modality of persistent adenoma with a scarred base.
Detailed description
Although the majority of polyps are non-malignant, it is known that the risk of malignancy increases with polyp size, with polyps < 10 mm having < 1% risk of cancer, polyps of 10 mm having a 10% risk of cancer and polyps of 20 mm having a greater than 10% risk of cancer. It is also understood that a polyp of < 1 cm takes approximately 10 years to transform into invasive colorectal carcinoma. Therefore, adenomas greater than 5 mm are normally treated. Polyps with tethered bases resulting from scarring are often the most challenging to resect endoscopically. The scarring can be caused by previous attempts at resection, previous deep biopsies, or tattoos placed too closely. These polyps often do not lift and can be impossible to snare even when stiff snares are used. Endoscopic submucosal dissection (ESD) and knife-assisted resection (KAR) are techniques that have been shown effective in the management of scarred polyps, however these techniques have not been widely adopted in the West. Argon plasma coagulation has been more commonly used to ablate adenomatous tissue in scarred polyps but this technique does not allow for the histological assessment of the scarred polyp and is less effective than ESD. The EndoRotor provides a technique whereby the lesion can be effectively removed without adjunct procedures with collection of tissue for histological assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Post-market, prospective, non-randomized, multi-center study for the treatment of subjects with the need for resection of recurrent flat or sessile colorectal lesions where EndoRotor is the primary resection modality of persistent adenoma with a scarred base.
| Arm | Type | Receives |
|---|---|---|
| EndoRotor Resection Arm | Other | Device: EndoRotor ResectionAll participants enrolled in this study will undergo treatment with the EndoRotor during colonoscopy for endoscopic mucosal resection in the colon to resect and remove tissue, not intended for biopsy, of the gastrointestinal system including post-endoscopic endoscopic mucosal resection of tissue persistence with a scarred base and residual tissue from peripheral margins following endoscopic mucosal resection. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects aged ≥18 to ≤85 years.
- At least one recurrent flat or sessile colorectal lesion measuring up to 6 cm in diameter and/or length.
- Presence of recurrent flat or sessile lesion where the EndoRotor may be used to resect recurrent neoplasia.
- Favorable anatomy that allows the investigator to access the lesion.
- Subject is able and willing to comply with site standard medical follow-up, including the 90-day follow-up visit.
Key exclusion criteria (12 listed)
- Inability to give informed consent.
- Subject age is <18 years of age or >85 years of age.
- Presence of a lesion that represents cancer or has a high chance of harboring submucosal invasive cancer.
- Presence of synchronous lesions intended for resection that would require use of a concomitant resection modality
- Medical reasons the procedure cannot be performed (i.e. labile blood pressure, anticoagulation laboratory levels that are too high and risk excessive bleeding, systemic infection, etc.)
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 |
|---|---|---|
| EndoRotor ResectionThe EndoRotor® is a powered cutting cannula for the removal of alimentary tract mucosa. Cutting is performed by aspirating tissue into a rotating cutting window. The resected tissue is immediately aspirated away from the resection site and collected in the EndoRotor Specimen Trap. The tissue can then be sent for pathological examination using standard methods. The system consists of a power console, foot control, specimen trap with pre-loaded filter and the applied part, which is the single-use catheter. | Device | EndoRotor Resection Arm |
Primary outcome
Primary Effectiveness Endpoint Defined as the Ability of the EndoRotor to Resect Lesions Without Concomitant Use of Other Resection Modalities and With no Device-related Serious Adverse Events Through the 90 Day Post Procedure Follow-up Visit.
Time frame: Index Procedure through 90 Day Post Procedure Follow-up Visit
Primary Safety Analysis Defined as the Occurrence of Serious Adverse Events Related to the EndoRotor Device as Measured From the Index Procedure Through the 90 Day Post Procedure Follow-up Visit.
Time frame: Index Procedure through 90 Day Post Procedure Follow-up Visit
4 secondary outcomes
Efficacy Defined as the Number of Participants Where EndoRotor Was Able to Resect the Entire Lesion in a Single Procedure.
Time frame: Index Procedure
Post-resection Stenosis Defined as the Occurrence of Colon Stenosis Following the Index Procedure.
Time frame: 90-day follow-up visit
Rate of Disease Persistence Defined as Remnant Disease at the Location of the Index Resection as Determined Endoscopically by the Investigator at the 90 Day Follow-up Visit.
Time frame: 90-day follow-up visit
Histologic Assessment Defined as the the Diagnostic Value of the Specimens Collected in the EndoRotor Specimen Trap (Could a Diagnosis be Rendered).
Time frame: 90-day follow-up visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38042207Knabe M, Maselli R, Cesbron-Metivier E, Hollerbach S, Petruzziello L, Prat F, Khara HS, Pioche M, Hartmann D, Cesaro P, Barbaro F, Berger A, Spada C, Diehl DL, May A, Ponchon T, Repici A, Costamagna G. Endoscopic powered resection device for residual colonic lesions: the first multicenter, prospective, international clinical study. Gastrointest Endosc. 2024 May;99(5):778-786. doi: 10.1016/j.gie.2023.11.050. Epub 2023 Dec 1.
- 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.
Guido Costamagna, MD principal investigator
Principal Investigator
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndoRotor Resection in people with Polyp of Colon and Endoscopic Mucosal Resection, run by Interscope, Inc. at 11 sites in 4 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 6 inclusion and 12 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 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, France, Italy, 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?
Yes. Results are posted in the registry (first posted 5 Apr 2022). 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?
Primary Effectiveness Endpoint Defined as the Ability of the EndoRotor to Resect Lesions Without Concomitant Use of Other Resection Modalities and With no Device-related Serious Adverse Events Through the 90 Day Post Procedure Follow-up Visit. (time frame: Index Procedure through 90 Day Post Procedure Follow-up Visit). 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 NCT04203667, 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 5 Apr 2022.