Colon AdenomaNCT03551379
A Double Balloon Endoscopic Platform for ESD
An observational study of Colon Adenoma and Colon Polyp, run by Lumendi, LLC at 1 site in United States.
Trial summary
The purpose of this observational study is to record performance of a double balloon endolumenal interventional platform during complex colon polypectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Adenoma, Colon Polyp
- What is being tested?
- Double Balloon Endoluminal Platform
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2017to 29 Sep 2018
- 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 with documented complex large intestinal polyps
Who may be able to join
- Subjects > 18 years of age
- Subjects scheduled for endoscopic removal of suspected complex adenomatous polyps in the large intestine which are sessile or polypoid lesions ≥ 2cm, near the ileocecal valve, dentate line, over a fold, or at a flexure; and or lesions tethered to the colon wall due to previous incomplete resection
- Subjects willing and able to give informed consent
- Subjects who in the opinion of the Principal Investigator have no medical contraindication to endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD)
Who cannot join
- Subjects with a contraindication to colonoscopy, including but not limited to active colitis, perforation, or stricture.
- Subjects with a history of open or laparoscopic colorectal surgery
- Subjects with a history of Inflammatory Bowel Disease (IBD)
- Subjects with a suspected malignancy on polyp assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Center Prospective Evaluation Utilizing a Double Balloon Accessory Device to Facilitate Complex Endoscopic Polypectomy in Large Intestine
The purpose of this observational study is to record performance of a double balloon endolumenal interventional platform during complex colon polypectomy.
Read the detailed description
Endoscopic removal of Complex colon polyps (benign polyps >=2cm) is a technically challenging procedure. Complex benign polyps have a greater chance of becoming cancerous if not removed.
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. 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 study will evaluate performance of the device during routine, scheduled, endoscopic polyp removal for these large polyps.
- Conditions
- Colon Adenoma, Colon Polyp
- Being tested
- Double Balloon Endoluminal Platform
- Keywords
- Endoscopic Submucosal Dissection
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double Balloon Endoluminal PlatformDevice
A DBA platform will be use din this registry study to facilitate ESD
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic procedure | A double balloon endoscopic platform will be used during an ESD procedure Receives: Device: Double Balloon Endoluminal Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to remove the complex polyp endoscopically
Was the lesion(s) able to be removed using the DiLumen Endolumenal Interventional Platform Device [Yes/No]
Measured: Duration of Procedure
Time taken for lesion removal
Time for lesion(s) removal with the double balloon device after intervention begins
Measured: Intervention start time until Lesion removal
Device or Procedural Adverse Events
Colon perforation, colon mucosal injury, excess bleeding will be recorded
Measured: Up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start22 Sep 2017
- Primary completion9 Mar 2018
- Study completion29 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon AdenomaStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumendi, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stavros Stavropoulos, MD, Principal investigator, Winthrop-NYU Langone Mineola, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551379
- Sponsor's protocol ID
- DD-017
- Status last verified
- Aug 2019
- First submitted
- 8 May 2018
- Last updated
- 20 Aug 2019
- 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 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center Prospective Evaluation Utilizing a Double Balloon Accessory Device to Facilitate Complex Endoscopic Polypectomy in Large Intestine
- ClinicalTrials.gov ID
- NCT03551379
- Acronym / sponsor ID
- DD-017
- Conditions
- Colon Adenoma, Colon Polyp
- Keywords
- Endoscopic Submucosal Dissection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Lumendi, LLCIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- 9 Mar 2018 (actual)
- Study completion
- 29 Sep 2018 (actual)
- First posted
- 11 Jun 2018 (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.
The purpose of this observational study is to record performance of a double balloon endolumenal interventional platform during complex colon polypectomy.
Detailed description
Endoscopic removal of Complex colon polyps (benign polyps >=2cm) is a technically challenging procedure. Complex benign polyps have a greater chance of becoming cancerous if not removed.
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. 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 study will evaluate performance of the device during routine, scheduled, endoscopic polyp removal for these large polyps.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic procedure | – | Device: Double Balloon Endoluminal PlatformA double balloon endoscopic platform will be used during an ESD procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with documented complex large intestinal polyps
Key inclusion criteria (4 listed)
- Subjects > 18 years of age
- Subjects scheduled for endoscopic removal of suspected complex adenomatous polyps in the large intestine which are sessile or polypoid lesions ≥ 2cm, near the ileocecal valve, dentate line, over a fold, or at a flexure; and or lesions tethered to the colon wall due to previous incomplete resection
- Subjects willing and able to give informed consent
- Subjects who in the opinion of the Principal Investigator have no medical contraindication to endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD)
Key exclusion criteria (4 listed)
- Subjects with a contraindication to colonoscopy, including but not limited to active colitis, perforation, or stricture.
- Subjects with a history of open or laparoscopic colorectal surgery
- Subjects with a history of Inflammatory Bowel Disease (IBD)
- Subjects with a suspected malignancy on polyp assessment
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 |
|---|---|---|
| Double Balloon Endoluminal PlatformA DBA platform will be use din this registry study to facilitate ESD | Device | Endoscopic procedure |
Primary outcome
Ability to remove the complex polyp endoscopically
Time frame: Duration of Procedure
Was the lesion(s) able to be removed using the DiLumen Endolumenal Interventional Platform Device [Yes/No]
Time taken for lesion removal
Time frame: Intervention start time until Lesion removal
Time for lesion(s) removal with the double balloon device after intervention begins
Device or Procedural Adverse Events
Time frame: Up to 72 hours
Colon perforation, colon mucosal injury, excess bleeding will be recorded
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 20 Aug 2019.
- 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.
Stavros Stavropoulos, MD principal investigator
Winthrop-NYU Langone Mineola, NY
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 Adenoma and 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 4 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 20 Aug 2019. 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?
Ability to remove the complex polyp endoscopically (time frame: Duration of Procedure). 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 20 Aug 2019.