Colon PolypNCT03113578
Evaluation of the DiLumen Device During Colonoscopy
An observational study of Colon Polyp, run by Lumendi, LLC at 1 site in United States.
Trial summary
This is an observational registry study collecting data on the clinical performance of the study device (DiLumen™ ) for its intended use. The primary objective is to evaluate functional outcomes of the DiLumen device in humans. The secondary objective is to evaluate safety characteristics of the DiLumen device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Polyp
- What is being tested?
- DiLumen
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2017to 27 Sep 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients listed for routine surveillance colonoscopy for colorectal cancer.
Who may be able to join
- Patients listed for routine surveillance colonoscopy for colorectal cancer and capable of giving informed consent
Who cannot join
- No patients less than 18 years of age.
- Any contraindication to routine surveillance colonoscopy
- History of open or laparoscopic colorectal surgery
- History of Inflammatory Bowel Disease
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Presbyterian Hospital
New York, New York, 10065
About this study
Official title: First-in-Human, Single Center, Evaluation of the DiLumen Device in Routine Colonoscopy
This is an observational registry study collecting data on the clinical performance of the study device (DiLumen™ ) for its intended use. The primary objective is to evaluate functional outcomes of the DiLumen device in humans. The secondary objective is to evaluate safety characteristics of the DiLumen device.
Read the detailed description
The DiLumen™ Endolumenal Interventional Platform is a non-sterile, single-use, close-fitting sleeve that fits securely over a standard endoscope to stabilize it in the large intestine, and facilitates use of the endoscope for optical visualization, diagnosis, and treatment. It was developed by MINT (Minimally Invasive New Technology) at Weill Cornell. The technology has been licensed to Lumendi for commercialization.
The DiLumen Endolumenal Interventional Platform ("DiLumen" or "the device") is an accessory to an endoscope. The DiLumen dual balloon accessory is intended for use with any standard endoscope that has a distal tip outer diameter of 12.5 - 14.3 mm and a working length of 1680 mm or greater. The device is indicated to ensure complete positioning of an endoscope in the large intestine and assist with optical visualization, diagnosis, and endoscopic treatment.
The device received 510k clearance on Dec 6, 2016. The device is fully disposable, and consists of six major components that form its primary mechanical structure: (1) Fore Balloon; (2) Aft Balloon; (3) Sleeve; (4) Base; (5) Push Rod Mechanism; and (6) Inflation System.
The DiLumen utilizes two balloons to position and stabilize the endoscope within a patient's large intestine. After the device is installed over the endoscope, the endoscope/DiLumen are navigated to the target zone with the balloons deflated. The first balloon, the Aft balloon, is attached to the DiLumen sleeve. Once the clinician is at the target site, the Aft Balloon will be inflated until it contacts the intestinal wall near the proximal end of the articulating section of an endoscope. The second balloon, the Fore Balloon, is also attached to the sleeve via two flexible extension Push Rods and is deployed at the distal end of the endoscope at a variable distance. Once extended and inflated, the Fore Balloon contacts the patient's intestinal wall, and in combination with the Aft Balloon, creates an isolated diagnostic or therapeutic zone within a patient's large intestine. Both balloons are inflated or deflated with ambient air independently using an Inflation Handle with a squeeze bulb. The balloons assist with accessing and visualization of lesions behind folds and turns in the intestine, stabilizing the endoscope distal tip and establishing a Therapeutic Zone (TZ). Required insufflation within the therapeutic zone is minimized compared to typical colorectal endoscopic procedures, because the balloons enclose only a small portion (approximately 23 cm) of the large intestine.
The balloons and sleeve are designed to permit the usage of any standard endoscopic tool (such as biopsy forceps, snare, needle, etc.) through the endoscope working channel. The endoscope flexibility, maneuverability and functionalities (such as visualization, suction, insufflations, etc.) are unaffected by the presence of the DiLumen.
- Conditions
- Colon Polyp
- Being tested
- DiLumen
- Keywords
- Balloon enteroscopy, colonoscopy, polyps
- Medical subject headings
- Colonic Polyps, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiLumenDevice
Also called Endolumenal Interventional Platform
The study device is placed over a compatible endoscope to facilitate endoscopic diagnosis and treatment of any large intestine pathology with the use of double balloons
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance
Ability to reach cecum with the study device and scope [Y or N]
Measured: Duration of procedure
Secondary outcomes (2)
Incidence of Treatment Related Adverse Events
No unintended visible mucosal injury on Dilumen withdrawal (above what is normally expected from colonoscopy)
Measured: Up to 3 months
Performance
Ability to inflate balloons in right colon and sigmoid colon and create a therapeutic zone [Y or N]
Measured: Duration of Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start26 Apr 2017
- Primary completion27 Sep 2017
- Study completion27 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon PolypStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumendi, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Weill Medical College of Cornell University
- Responsible party
- Principal investigator, Reem Sharaiha, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113578
- Sponsor's protocol ID
- DD-009
- Other IDs
- 1610017641
- Status last verified
- Nov 2017
- First submitted
- 15 Mar 2017
- Last updated
- 2 Dec 2017
- 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 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-Human, Single Center, Evaluation of the DiLumen Device in Routine Colonoscopy
- ClinicalTrials.gov ID
- NCT03113578
- Acronym / sponsor ID
- DD-009
- Conditions
- Colon Polyp
- Keywords
- Balloon enteroscopy, colonoscopy, polyps
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Lumendi, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Weill Medical College of Cornell University
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- 27 Sep 2017 (actual)
- Study completion
- 27 Sep 2017 (actual)
- First posted
- 13 Apr 2017 (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 is an observational registry study collecting data on the clinical performance of the study device (DiLumen™ ) for its intended use. The primary objective is to evaluate functional outcomes of the DiLumen device in humans. The secondary objective is to evaluate safety characteristics of the DiLumen device.
Detailed description
The DiLumen™ Endolumenal Interventional Platform is a non-sterile, single-use, close-fitting sleeve that fits securely over a standard endoscope to stabilize it in the large intestine, and facilitates use of the endoscope for optical visualization, diagnosis, and treatment. It was developed by MINT (Minimally Invasive New Technology) at Weill Cornell. The technology has been licensed to Lumendi for commercialization.
The DiLumen Endolumenal Interventional Platform ("DiLumen" or "the device") is an accessory to an endoscope. The DiLumen dual balloon accessory is intended for use with any standard endoscope that has a distal tip outer diameter of 12.5 - 14.3 mm and a working length of 1680 mm or greater. The device is indicated to ensure complete positioning of an endoscope in the large intestine and assist with optical visualization, diagnosis, and endoscopic treatment.
The device received 510k clearance on Dec 6, 2016. The device is fully disposable, and consists of six major components that form its primary mechanical structure: (1) Fore Balloon; (2) Aft Balloon; (3) Sleeve; (4) Base; (5) Push Rod Mechanism; and (6) Inflation System.
The DiLumen utilizes two balloons to position and stabilize the endoscope within a patient's large intestine. After the device is installed over the endoscope, the endoscope/DiLumen are navigated to the target zone with the balloons deflated. The first balloon, the Aft balloon, is attached to the DiLumen sleeve. Once the clinician is at the target site, the Aft Balloon will be inflated until it contacts the intestinal wall near the proximal end of the articulating section of an endoscope. The second balloon, the Fore Balloon, is also attached to the sleeve via two flexible extension Push Rods and is deployed at the distal end of the endoscope at a variable distance. Once extended and inflated, the Fore Balloon contacts the patient's intestinal wall, and in combination with the Aft Balloon, creates an isolated diagnostic or therapeutic zone within a patient's large intestine. Both balloons are inflated or deflated with ambient air independently using an Inflation Handle with a squeeze bulb. The balloons assist with accessing and visualization of lesions behind folds and turns in the intestine, stabilizing the endoscope distal tip and establishing a Therapeutic Zone (TZ). Required insufflation within the therapeutic zone is minimized compared to typical colorectal endoscopic procedures, because the balloons enclose only a small portion (approximately 23 cm) of the large intestine.
The balloons and sleeve are designed to permit the usage of any standard endoscopic tool (such as biopsy forceps, snare, needle, etc.) through the endoscope working channel. The endoscope flexibility, maneuverability and functionalities (such as visualization, suction, insufflations, etc.) are unaffected by the presence of the DiLumen.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients listed for routine surveillance colonoscopy for colorectal cancer.
Key inclusion criteria (1 listed)
- Patients listed for routine surveillance colonoscopy for colorectal cancer and capable of giving informed consent
Key exclusion criteria (4 listed)
- No patients less than 18 years of age.
- Any contraindication to routine surveillance colonoscopy
- History of open or laparoscopic colorectal surgery
- History of Inflammatory Bowel Disease
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 |
|---|---|---|
| DiLumenAlso: Endolumenal Interventional PlatformThe study device is placed over a compatible endoscope to facilitate endoscopic diagnosis and treatment of any large intestine pathology with the use of double balloons | Device | – |
Primary outcome
Performance
Time frame: Duration of procedure
Ability to reach cecum with the study device and scope [Y or N]
2 secondary outcomes
Incidence of Treatment Related Adverse Events
Time frame: Up to 3 months
Performance
Time frame: Duration of Procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Polyp, run by Lumendi, LLC 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 1 inclusion and 4 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 2 Dec 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Performance (time frame: Duration of 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 2 Dec 2017.