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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.
This is a prospective, post-market, randomized clinical trial comparing colonic ESD procedures utilizing the DiLumenâ„¢ Endolumenal Interventional Platform to colonic ESD procedures that are performed without use the DiLumenâ„¢ 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 DiLumenâ„¢ device. The control group will consist of up to 100 subjects treated without DiLumenâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| double balloon platform | Experimental | Device: double balloon interventional platform (DiLumen) |
|
| no double balloon platform | Active Comparator | Device: no double balloon interventional platform (DiLumen) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| double balloon interventional platform (DiLumen) | Device | double balloon interventional platform (DiLumen) is used for removal of colonic polyp |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total case time | Time from the beginning of procedure until the end of the entire procedure Iin minutes) | 3-month |
| Measure | Description | Time Frame |
|---|---|---|
| Navigation time | Time from endoscope insertion into patient's rectum till colonic lesion is reached (in minutes) | 3-month |
| Dissection time | Time from the start of lesion removal till the lesion removal is completed (in minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sergey V Kantsevoy, MD, PhD | Director of The Therapeutic Endoscopy Mercy Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercy Medical Center | Baltimore | Maryland | 21202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38971202 | Derived | 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. |
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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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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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)]
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The patients will be randomly assigned to study or control group. The patients will not know their assignment until completion of the study.
| no double balloon interventional platform (DiLumen) | Device | double balloon interventional platform (DiLumen) is not used for removal of colonic polyp |
|
| 3-month |
| Length of Hospital Stay | Days of admission to the hospital post procedure till the patient is discharged from the hospital (in days) | 3-month |
| Cost of service | Total financial cost (in USA dollars) of the medical care received pertaining to the procedure and related follow-up | 3-month |
| 30-day readmittance rate | Number of patients readmitted to the hospital during first 30 days post colonoscopy | 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. | 3-month |
| Histologic pathology summary | The final pathological determination of the excised specimen, as determined by pathological examination | 3-month |
| Rate of complications | Adverse effects that occur during the study | 3-month |