Colonic PolypNCT03846609
Evaluation of a Double Balloon Interventional Platform (DiLumen) for Complex Colonic ESD
A study testing double balloon interventional platform (DiLumen) and no double balloon interventional platform (DiLumen) in people with Colonic Polyp, run by Mercy Medical Center at 1 site in United States.
Trial summary
The purpose of this randomized study is to compare ESD procedural time and cost facilitated with a dual balloon accessory device versus ESD procedures performed without the accessory device. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colonic Polyp
- What is being tested?
- double balloon interventional platform (DiLumen) and no double balloon interventional platform (DiLumen)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2019to 10 Dec 2020
- Phase
- Interventional
- 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
Who may be able to join
- Men or women 18-85 years of age.
- Have ability to understand the requirements of the study and provide written informed consent
- Suspected complex adenomatous polyps in the large intestine defined as sessile or polypoid lesions 2 cm and larger in size.
- No medical contraindication to endoscopic submucosal dissection (ESD).
Who cannot join
- Contraindication to colonoscopy, such as active colitis, diverticulitis, perforation, or stricture.
- History of open or laparoscopic colorectal surgery.
- History of Inflammatory Bowel Disease (IBD).
- Any medical or surgical condition that would preclude the endoscopic removal of the polyp.
- Anatomy or other factors that prohibit safe access to the large intestine such as previous radiation therapy to the affected area, known colonic strictures, extensive colonic diverticuli, etc.
- History of AIDS, HIV, or active hepatitis.
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- 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.
- Patients who are pregnant or lactating.
- Currently involved in another investigational product for similar purposes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Study Evaluating the Performance of a Double Balloon Interventional Platform (DiLumen) for Facilitating Complex Colonic ESD
The purpose of this randomized study is to compare ESD procedural time and cost facilitated with a dual balloon accessory device versus ESD procedures performed without the accessory device. Study is designed to detect if the double balloon interventional platform helps to perform removal of benign complex colonic lesions safer and in more efficient way.
Read the detailed description
This is a prospective, post-market, randomized clinical trial comparing colonic ESD procedures utilizing the DiLumen™ Endolumenal Interventional Platform to colonic ESD procedures that are performed without use the DiLumen™ device.
The study participants will be randomly assigned to study group and control group The treatment group will consist of up to 100 subjects treated with the DiLumen™ device. The control group will consist of up to 100 subjects treated without DiLumen™ device. Assessments will include procedure timepoints, anesthesia use, polyp location and classification, over-all cost assessment, and general complications.
The primary outcome will be analyzed using parametric statistics to compare the means of the study and control groups. P-values and confidence intervals will be reported. Descriptive and summary statistics will also be employed. Secondary outcomes will be summarized with descriptive statistics.
- Conditions
- Colonic Polyp
- Being tested
- double balloon interventional platform (DiLumen), no double balloon interventional platform (DiLumen)
- 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 interventional platform (DiLumen)Device
double balloon interventional platform (DiLumen) is used for removal of colonic polyp
no double balloon interventional platform (DiLumen)Device
double balloon interventional platform (DiLumen) is not used for removal of colonic polyp
| Study group | Role | What they receive |
|---|---|---|
| double balloon platform | Experimental | Device: double balloon interventional platform (DiLumen) Receives: Device: double balloon interventional platform (DiLumen) |
| no double balloon platform | Active comparator | Device: no double balloon interventional platform (DiLumen) Receives: Device: no double balloon interventional platform (DiLumen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total case time
Time from the beginning of procedure until the end of the entire procedure Iin minutes)
Measured: 3-month
Secondary outcomes (8)
Navigation time
Time from endoscope insertion into patient's rectum till colonic lesion is reached (in minutes)
Measured: 3-month
Dissection time
Time from the start of lesion removal till the lesion removal is completed (in minutes)
Measured: 3-month
Length of Hospital Stay
Days of admission to the hospital post procedure till the patient is discharged from the hospital (in days)
Measured: 3-month
Cost of service
Total financial cost (in USA dollars) of the medical care received pertaining to the procedure and related follow-up
Measured: 3-month
30-day readmittance rate
Number of patients readmitted to the hospital during first 30 days post colonoscopy
Measured: 30-day
Patient satisfaction survey
Patients are given three statements regarding their procedures for which they answer if they agree or disagree with the statement.
Measured: 3-month
Histologic pathology summary
The final pathological determination of the excised specimen, as determined by pathological examination
Measured: 3-month
Rate of complications
Adverse effects that occur during the study
Measured: 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start19 Feb 2019
- Primary completion15 Mar 2020
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be assigned into study group \[procedure performed with use of double balloon interventional platform (DiLumen)\] or control group \[procedure done without the use of double balloon interventional platform (DiLumen)\]
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mercy Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergey Kantsevoy, M.D., Ph.D., Mercy Medical Center
- Investigators
- Sergey V Kantsevoy, MD, PhD, Principal investigator, Director of The Therapeutic Endoscopy Mercy Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846609
- Sponsor's protocol ID
- 1368768-2
- Status last verified
- Dec 2020
- First submitted
- 12 Feb 2019
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Study records should be stored in a secure area to limit access to study personnel and maintain confidentiality of the records.
Publications
Kantsevoy SV, Palmer A, Hockett D, Vilches A. Prospective, randomized controlled study evaluating a double-balloon interventional endoscopic platform for colorectal endoscopic submucosal dissection (with video). Gastrointest Endosc. 2025 Jan;101(1):149-157. doi: 10.1016/j.gie.2024.07.001. Epub 2024 Jul 5.
PubMed 38971202
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
- A Randomized Controlled Study Evaluating the Performance of a Double Balloon Interventional Platform (DiLumen) for Facilitating Complex Colonic ESD
- ClinicalTrials.gov ID
- NCT03846609
- Acronym / sponsor ID
- 1368768-2
- Conditions
- Colonic Polyp
- Keywords
- Endoscopic Submucosal Dissection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Mercy Medical CenterUniversity, hospital or other
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 19 Feb 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.
The purpose of this randomized study is to compare ESD procedural time and cost facilitated with a dual balloon accessory device versus ESD procedures performed without the accessory device. Study is designed to detect if the double balloon interventional platform helps to perform removal of benign complex colonic lesions safer and in more efficient way.
Detailed description
This is a prospective, post-market, randomized clinical trial comparing colonic ESD procedures utilizing the DiLumen™ Endolumenal Interventional Platform to colonic ESD procedures that are performed without use the DiLumen™ device.
The study participants will be randomly assigned to study group and control group The treatment group will consist of up to 100 subjects treated with the DiLumen™ device. The control group will consist of up to 100 subjects treated without DiLumen™ device. Assessments will include procedure timepoints, anesthesia use, polyp location and classification, over-all cost assessment, and general complications.
The primary outcome will be analyzed using parametric statistics to compare the means of the study and control groups. P-values and confidence intervals will be reported. Descriptive and summary statistics will also be employed. Secondary outcomes will be summarized with descriptive statistics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The patients will be assigned into study group [procedure performed with use of double balloon interventional platform (DiLumen)] or control group [procedure done without the use of double balloon interventional platform (DiLumen)]
| Arm | Type | Receives |
|---|---|---|
| double balloon platform | Experimental | Device: double balloon interventional platform (DiLumen)Device: double balloon interventional platform (DiLumen) |
| no double balloon platform | Active comparator | Device: no double balloon interventional platform (DiLumen)Device: no double balloon interventional platform (DiLumen) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women 18-85 years of age.
- Have ability to understand the requirements of the study and provide written informed consent
- Suspected complex adenomatous polyps in the large intestine defined as sessile or polypoid lesions 2 cm and larger in size.
- No medical contraindication to endoscopic submucosal dissection (ESD).
Key exclusion criteria (9 listed)
- Contraindication to colonoscopy, such as active colitis, diverticulitis, perforation, or stricture.
- History of open or laparoscopic colorectal surgery.
- History of Inflammatory Bowel Disease (IBD).
- Any medical or surgical condition that would preclude the endoscopic removal of the polyp.
- Anatomy or other factors that prohibit safe access to the large intestine such as previous radiation therapy to the affected area, known colonic strictures, extensive colonic diverticuli, 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 |
|---|---|---|
| double balloon interventional platform (DiLumen)double balloon interventional platform (DiLumen) is used for removal of colonic polyp | Device | double balloon platform |
| no double balloon interventional platform (DiLumen)double balloon interventional platform (DiLumen) is not used for removal of colonic polyp | Device | no double balloon platform |
Primary outcome
Total case time
Time frame: 3-month
Time from the beginning of procedure until the end of the entire procedure Iin minutes)
8 secondary outcomes
Navigation time
Time frame: 3-month
Dissection time
Time frame: 3-month
Length of Hospital Stay
Time frame: 3-month
Cost of service
Time frame: 3-month
30-day readmittance rate
Time frame: 30-day
Patient satisfaction survey
Time frame: 3-month
Histologic pathology summary
Time frame: 3-month
Rate of complications
Time frame: 3-month
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 11 Dec 2020.
- Derived from this study: PubMed 38971202Kantsevoy SV, Palmer A, Hockett D, Vilches A. Prospective, randomized controlled study evaluating a double-balloon interventional endoscopic platform for colorectal endoscopic submucosal dissection (with video). Gastrointest Endosc. 2025 Jan;101(1):149-157. doi: 10.1016/j.gie.2024.07.001. Epub 2024 Jul 5.
- Individual participant dataSharing planned: No. Study records should be stored in a secure area to limit access to study personnel and maintain confidentiality of the records.
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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.
Sergey V Kantsevoy, MD, PhD principal investigator
Director of The Therapeutic Endoscopy Mercy Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing double balloon interventional platform (DiLumen) and no double balloon interventional platform (DiLumen) in people with Colonic Polyp, run by Mercy Medical Center 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 9 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 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 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?
Total case time (time frame: 3-month). 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 NCT03846609, 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 11 Dec 2020.