Back to resultsEvaluation of a Double Balloon Interventional Platform (DiLumen) for Complex Colonic ESD
Primary Purpose
Colonic Polyp
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
double balloon interventional platform (DiLumen)
no double balloon interventional platform (DiLumen)
Sponsored by
About this trial
This is an interventional treatment trial for Colonic Polyp focused on measuring Endoscopic Submucosal Dissection
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Mercy Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
double balloon platform
no double balloon platform
Arm Description
Device: double balloon interventional platform (DiLumen)
Device: no double balloon interventional platform (DiLumen)
Outcomes
Primary Outcome Measures
Total case time
Time from the beginning of procedure until the end of the entire procedure Iin minutes)
Secondary Outcome Measures
Navigation time
Time from endoscope insertion into patient's rectum till colonic lesion is reached (in minutes)
Dissection time
Time from the start of lesion removal till the lesion removal is completed (in minutes)
Length of Hospital Stay
Days of admission to the hospital post procedure till the patient is discharged from the hospital (in days)
Cost of service
Total financial cost (in USA dollars) of the medical care received pertaining to the procedure and related follow-up
30-day readmittance rate
Number of patients readmitted to the hospital during first 30 days post colonoscopy
Patient satisfaction survey
Patients are given three statements regarding their procedures for which they answer if they agree or disagree with the statement.
Histologic pathology summary
The final pathological determination of the excised specimen, as determined by pathological examination
Rate of complications
Adverse effects that occur during the study
Full Information
NCT ID
NCT03846609
First Posted
February 12, 2019
Last Updated
December 10, 2020
Sponsor
Mercy Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03846609
Brief Title
Evaluation of a Double Balloon Interventional Platform (DiLumen) for Complex Colonic ESD
Official Title
A Randomized Controlled Study Evaluating the Performance of a Double Balloon Interventional Platform (DiLumen) for Facilitating Complex Colonic ESD
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
February 19, 2019 (Actual)
Primary Completion Date
March 15, 2020 (Actual)
Study Completion Date
December 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mercy Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyp
Keywords
Endoscopic Submucosal Dissection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
The patients will be randomly assigned to study or control group. The patients will not know their assignment until completion of the study.
Allocation
Randomized
Enrollment
147 (Actual)
8. Arms, Groups, and Interventions
Arm Title
double balloon platform
Arm Type
Experimental
Arm Description
Device: double balloon interventional platform (DiLumen)
Arm Title
no double balloon platform
Arm Type
Active Comparator
Arm Description
Device: no double balloon interventional platform (DiLumen)
Intervention Type
Device
Intervention Name(s)
double balloon interventional platform (DiLumen)
Intervention Description
double balloon interventional platform (DiLumen) is used for removal of colonic polyp
Intervention Type
Device
Intervention Name(s)
no double balloon interventional platform (DiLumen)
Intervention Description
double balloon interventional platform (DiLumen) is not used for removal of colonic polyp
Primary Outcome Measure Information:
Title
Total case time
Description
Time from the beginning of procedure until the end of the entire procedure Iin minutes)
Time Frame
3-month
Secondary Outcome Measure Information:
Title
Navigation time
Description
Time from endoscope insertion into patient's rectum till colonic lesion is reached (in minutes)
Time Frame
3-month
Title
Dissection time
Description
Time from the start of lesion removal till the lesion removal is completed (in minutes)
Time Frame
3-month
Title
Length of Hospital Stay
Description
Days of admission to the hospital post procedure till the patient is discharged from the hospital (in days)
Time Frame
3-month
Title
Cost of service
Description
Total financial cost (in USA dollars) of the medical care received pertaining to the procedure and related follow-up
Time Frame
3-month
Title
30-day readmittance rate
Description
Number of patients readmitted to the hospital during first 30 days post colonoscopy
Time Frame
30-day
Title
Patient satisfaction survey
Description
Patients are given three statements regarding their procedures for which they answer if they agree or disagree with the statement.
Time Frame
3-month
Title
Histologic pathology summary
Description
The final pathological determination of the excised specimen, as determined by pathological examination
Time Frame
3-month
Title
Rate of complications
Description
Adverse effects that occur during the study
Time Frame
3-month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergey V Kantsevoy, MD, PhD
Organizational Affiliation
Director of The Therapeutic Endoscopy Mercy Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Study records should be stored in a secure area to limit access to study personnel and maintain confidentiality of the records.
Learn more about this trial
Evaluation of a Double Balloon Interventional Platform (DiLumen) for Complex Colonic ESD
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