Polyps of ColonDiLumenC2NCT04657601
Prospective Study of a New Endolumenal Device Used During Endoscopic Polypectomy in the Colon
An observational study of Polyps of Colon, run by Lumendi, LLC.
Trial summary
This prospective observational study will evaluate the performance of the DiLumen C2 Endolumenal Interventional Platform and its instruments. Up to 100 subjects will be enrolled at up to 5 clinical sites. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Polyps of Colon
- What is being tested?
- DiLumen C2 Endolumenal Interventional Platform
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2021to Mar 2022
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subject population includes adults (ages 18-85 years) men and women scheduled to undergo a colorectal ESD. Subjects will be recruited from the investigator's standard patient population as seen in their routine clinical practice and will be screened for participation according to the protocol defined inclusion and exclusion criteria.
Who may be able to join
- Men or women 18-85 years of age.
- Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.
- Scheduled for endoscopic removal of suspected colorectal adenomatous polyps which are sessile or polypoid lesions.
- Have, in the opinion of the Investigator(s) or co-investigator(s), no medical contraindication to endoscopic submucosal dissection (ESD).
Who cannot join
- Have a contraindication to colonoscopy, including but not limited to active colitis, diverticulitis, perforation, or stricture.
- Have a history of open or laparoscopic colorectal surgery.
- Have a history of Inflammatory Bowel Disease (IBD).
- Have a suspected invasive malignancy on polyp assessment.
- Any medical or surgical condition that would preclude the potential benefit ESD.
- Any case where the device or instrument would be too large or too small to achieve a successful result.
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- Anatomy or other factors that prohibit safe access to the large intestine such as previous radiation therapy to the affected area.
- History of AIDS, HIV, or active hepatitis.
- History of mental illness, including psychological or neurological conditions (addiction to substances such as alcohol. e.g.) that in the investigator's opinion would pre-empt their ability or willingness to participate in the study.
- Has cardiopulmonary conditions that present prohibitive anesthesia risk.
- Has uncorrectable coagulopathy or hemorrhagic diathesis.
- Has an active infection or fever.
- Has allergy to any component of the treatment procedure.
- Patients who are pregnant.
- Pediatric case (Age < 18 years)
- Any case in which use of the DiLumen C2 device is not needed.
- Any case not described in the indications.
- Currently involved in another investigational product for similar purposes.
- Prisoners.
About this study
Official title: Prospective Evaluation Utilizing an Endolumenal Interventional Platform Device to Facilitate Endoscopic Polypectomy
This prospective observational study will evaluate the performance of the DiLumen C2 Endolumenal Interventional Platform and its instruments. Up to 100 subjects will be enrolled at up to 5 clinical sites. Patient data will be collected before the procedure, during the procedure, and up until the patient is discharged from the hospital.
Read the detailed description
This study is a prospective, post-market evaluation of the performance of the DiLumen C2 Endolumenal Interventional Platform ("C2 device") used as an endoscopic dual balloon accessory device used to ensure complete positioning, visualization, and diagnosis in endoscopic treatments in the large intestine. The DiLumen Endolumenal Interventional Knife ("IK device") and the DiLumen Endolumenal Interventional Grasper ("IG device") are disposable instruments used with the C2 device. These devices are cleared by the US Food and Drug Administration (FDA) for commercial use in endolumenal therapies and will be used on-label in this study. The overall goal of this study is to evaluate the clinical performance of the C2 device and its related instruments. Intra-procedure parameters (procedure timepoints, anesthesia use, polyp location and description), final pathology/histology, and general complications will also be evaluated. Investigators will also be asked to assess the ease of use of the C2Interventional Platform.
To accomplish this goal, up to 100 subjects will be enrolled at up to 5 clinical sites and treated using the C2 device and related instruments. Evaluations will be performed pre-procedure, during the procedure, and at discharge. Assessments will include polyp classification/pathology, procedure timepoints, final pathology/histology, adverse events, and ease of use. As per the FDA cleared product labeling this study will be limited to subjects undergoing an endoscopic procedure to remove polyps in the large intestine.
- Conditions
- Polyps of Colon
- Being tested
- DiLumen C2 Endolumenal Interventional Platform
- Keywords
- Intestinal Polyps, Pathologic Condition, Anatomical, Polyps
- Medical subject headings
- Colonic Polyps, Intestinal Polyps, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiLumen C2 Endolumenal Interventional PlatformDevice
Dual balloon accessory to an endoscope and related instruments
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Patients undergo polypectomy facilitated by the study device. Receives: Device: DiLumen C2 Endolumenal Interventional Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ability of the investigator to perform an endoscopic ESD safely and effectively
Whether or not the polyp was removed and if there were any adverse events
Measured: Through study completion, up to 7 days
Secondary outcomes (3)
Details of the procedure
Procedure time
Measured: Through study completion, up to 7 days
Details of the procedure
Dissection speed
Measured: Through study completion, up to 7 days
Legnth of Hospital Stay
How long the patient was in the hospital following the polypectomy
Measured: Through study completion, up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start15 Jan 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyps 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lumendi, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657601
- Sponsor's protocol ID
- USLUM 1802 or 2020-01
- Acronym
- DiLumenC2
- Status last verified
- Dec 2020
- First submitted
- 22 Oct 2020
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation Utilizing an Endolumenal Interventional Platform Device to Facilitate Endoscopic Polypectomy
- ClinicalTrials.gov ID
- NCT04657601
- Acronym / sponsor ID
- DiLumenC2 / USLUM 1802 or 2020-01
- Conditions
- Polyps of Colon
- Keywords
- Intestinal Polyps, Pathologic Condition, Anatomical, Polyps
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lumendi, LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 8 Dec 2020 (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.
This prospective observational study will evaluate the performance of the DiLumen C2 Endolumenal Interventional Platform and its instruments. Up to 100 subjects will be enrolled at up to 5 clinical sites. Patient data will be collected before the procedure, during the procedure, and up until the patient is discharged from the hospital.
Detailed description
This study is a prospective, post-market evaluation of the performance of the DiLumen C2 Endolumenal Interventional Platform ("C2 device") used as an endoscopic dual balloon accessory device used to ensure complete positioning, visualization, and diagnosis in endoscopic treatments in the large intestine. The DiLumen Endolumenal Interventional Knife ("IK device") and the DiLumen Endolumenal Interventional Grasper ("IG device") are disposable instruments used with the C2 device. These devices are cleared by the US Food and Drug Administration (FDA) for commercial use in endolumenal therapies and will be used on-label in this study. The overall goal of this study is to evaluate the clinical performance of the C2 device and its related instruments. Intra-procedure parameters (procedure timepoints, anesthesia use, polyp location and description), final pathology/histology, and general complications will also be evaluated. Investigators will also be asked to assess the ease of use of the C2Interventional Platform.
To accomplish this goal, up to 100 subjects will be enrolled at up to 5 clinical sites and treated using the C2 device and related instruments. Evaluations will be performed pre-procedure, during the procedure, and at discharge. Assessments will include polyp classification/pathology, procedure timepoints, final pathology/histology, adverse events, and ease of use. As per the FDA cleared product labeling this study will be limited to subjects undergoing an endoscopic procedure to remove polyps in the large intestine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | – | Device: DiLumen C2 Endolumenal Interventional PlatformPatients undergo polypectomy facilitated by the study device. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subject population includes adults (ages 18-85 years) men and women scheduled to undergo a colorectal ESD. Subjects will be recruited from the investigator's standard patient population as seen in their routine clinical practice and will be screened for participation according to the protocol defined inclusion and exclusion criteria.
Key inclusion criteria (4 listed)
- Men or women 18-85 years of age.
- Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.
- Scheduled for endoscopic removal of suspected colorectal adenomatous polyps which are sessile or polypoid lesions.
- Have, in the opinion of the Investigator(s) or co-investigator(s), no medical contraindication to endoscopic submucosal dissection (ESD).
Key exclusion criteria (19 listed)
- Have a contraindication to colonoscopy, including but not limited to active colitis, diverticulitis, perforation, or stricture.
- Have a history of open or laparoscopic colorectal surgery.
- Have a history of Inflammatory Bowel Disease (IBD).
- Have a suspected invasive malignancy on polyp assessment.
- Any medical or surgical condition that would preclude the potential benefit ESD.
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 |
|---|---|---|
| DiLumen C2 Endolumenal Interventional PlatformDual balloon accessory to an endoscope and related instruments | Device | Treatment Group |
Primary outcome
The ability of the investigator to perform an endoscopic ESD safely and effectively
Time frame: Through study completion, up to 7 days
Whether or not the polyp was removed and if there were any adverse events
3 secondary outcomes
Details of the procedure
Time frame: Through study completion, up to 7 days
Details of the procedure
Time frame: Through study completion, up to 7 days
Legnth of Hospital Stay
Time frame: Through study completion, up to 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Polyps of Colon, run by Lumendi, LLC.
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 19 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 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The ability of the investigator to perform an endoscopic ESD safely and effectively (time frame: Through study completion, up to 7 days). 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 8 Dec 2020; AzTrials last refreshed its copy on 6 Nov 2026.