Adenomatous Polyp of ColonNCT03942965
Registry Evaluation of a Double Balloon Accessory Device
An observational study of Adenomatous Polyp of Colon, run by Lumendi, LLC at 3 sites in United States.
Trial summary
This study is collecting standard of care information pertaining to the use of the accessory device and patient outcomes when this double balloon accessory device is used during endoscopic procedures in the colon. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenomatous Polyp of Colon
- What is being tested?
- Double balloon accessory device
- Type of treatment
- Medical device
- How many people
- 165 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Jan 2019to 31 Mar 2021
- How long will I take part?
- 30 Days
- 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: Investigator's practice
Who may be able to join
- Patients scheduled for endoscopic removal of suspected adenomatous benign polyps(s)
- Patients capable of giving informed consent in English
- No medical contraindication to endoscopic mucosal resection or endoscopic submucosal disection
Who cannot join
- No patients less than 18 years of age.
- Any contraindication to colonoscopy with due to subject's colon anatomy (i.e. stricture)
- History of open or laparoscopic colorectal surgery
- History of Inflammatory Bowel Disease
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Geisinger Health System
Danville, Pennsylvania, 17822
University of Florida - Division of Gastroenterology, Hepatology and Nutrition
Gainesville, Florida, 32610
Baylor College of Medicine
Houston, Texas, 77030
About this study
Official title: Multi-center Prospective Registry Study Utilizing a Double Balloon Accessory Device to Facilitate Endoscopic Polypectomy in Large Intestine.
This study is collecting standard of care information pertaining to the use of the accessory device and patient outcomes when this double balloon accessory device is used during endoscopic procedures in the colon.
- Conditions
- Adenomatous Polyp of Colon
- Being tested
- Double balloon accessory device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double balloon accessory deviceDevice
Also called DiLumen
Double balloon accessory device is used during the endoscopic polypectomy procedure
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to perform the procedure safely and effectively with the study device.
Investigator answers yes or no
Measured: Intraoperatively
Secondary outcomes (7)
Time to reach target lesion
Time measurement in hours and minutes
Measured: Intraoperatively
Time to remove lesion after intervention begins
Time measurement in hours and minutes
Measured: Intraoperatively
Total time using study device during case
Time measurement in hours and minutes
Measured: Intraoperatively
Total case time
Time measurement in hours and minutes
Measured: Intraoperatively
Total defect closure time
Time measurement in hours and minutes
Measured: Intraoperatively
User feedback on device performance
Investigator rates the ease of use (easy, somewhat easy, somewhat difficult and difficult) of the device.
Measured: Intraoperatively
Number of Study Subjects with Treatment Related Adverse Events
No moderate to severe mucosal injury, perforations or bleeding related to the use of the device.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start22 Jan 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenomatous 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Lumendi, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Draganov, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942965
- Sponsor's protocol ID
- DD_20
- Status last verified
- Dec 2020
- First submitted
- 3 May 2019
- Last updated
- 11 Dec 2020
- 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 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Prospective Registry Study Utilizing a Double Balloon Accessory Device to Facilitate Endoscopic Polypectomy in Large Intestine.
- ClinicalTrials.gov ID
- NCT03942965
- Acronym / sponsor ID
- DD_20
- Conditions
- Adenomatous Polyp of Colon
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Lumendi, LLCIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 8 May 2019 (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 study is collecting standard of care information pertaining to the use of the accessory device and patient outcomes when this double balloon accessory device is used during endoscopic procedures in the colon.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Investigator's practice
Key inclusion criteria (3 listed)
- Patients scheduled for endoscopic removal of suspected adenomatous benign polyps(s)
- Patients capable of giving informed consent in English
- No medical contraindication to endoscopic mucosal resection or endoscopic submucosal disection
Key exclusion criteria (4 listed)
- No patients less than 18 years of age.
- Any contraindication to colonoscopy with due to subject's colon anatomy (i.e. stricture)
- 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 |
|---|---|---|
| Double balloon accessory deviceAlso: DiLumenDouble balloon accessory device is used during the endoscopic polypectomy procedure | Device | – |
Primary outcome
Ability to perform the procedure safely and effectively with the study device.
Time frame: Intraoperatively
Investigator answers yes or no
7 secondary outcomes
Time to reach target lesion
Time frame: Intraoperatively
Time to remove lesion after intervention begins
Time frame: Intraoperatively
Total time using study device during case
Time frame: Intraoperatively
Total case time
Time frame: Intraoperatively
Total defect closure time
Time frame: Intraoperatively
User feedback on device performance
Time frame: Intraoperatively
Number of Study Subjects with Treatment Related Adverse Events
Time frame: Up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- 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.
Peter Draganov, MD principal investigator
University of Florida
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenomatous Polyp of Colon, run by Lumendi, LLC at 3 sites 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 3 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: status not confirmed, as of the sponsor's last update on 11 Dec 2020. 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 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?
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?
Ability to perform the procedure safely and effectively with the study device. (time frame: Intraoperatively). 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 11 Dec 2020.