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Evaluation of a Double Balloon Interventional Platform (DiLumen) for Complex Colonic ESD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03846609
Recruitment Status : Completed
First Posted : February 19, 2019
Last Update Posted : December 11, 2020
Sponsor:
Information provided by (Responsible Party):
Sergey Kantsevoy, M.D., Ph.D., Mercy Medical Center

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.

Condition or disease Intervention/treatment Phase
Colonic Polyp Device: double balloon interventional platform (DiLumen) Device: no double balloon interventional platform (DiLumen) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (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.
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study Evaluating the Performance of a Double Balloon Interventional Platform (DiLumen) for Facilitating Complex Colonic ESD
Actual Study Start Date : February 19, 2019
Actual Primary Completion Date : March 15, 2020
Actual Study Completion Date : December 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonic Polyps

Arm Intervention/treatment
Experimental: double balloon platform
Device: double balloon interventional platform (DiLumen)
Device: double balloon interventional platform (DiLumen)
double balloon interventional platform (DiLumen) is used for removal of colonic polyp

Active Comparator: no double balloon platform
Device: no double balloon interventional platform (DiLumen)
Device: no double balloon interventional platform (DiLumen)
double balloon interventional platform (DiLumen) is not used for removal of colonic polyp




Primary Outcome Measures :
  1. Total case time [ Time Frame: 3-month ]
    Time from the beginning of procedure until the end of the entire procedure Iin minutes)


Secondary Outcome Measures :
  1. Navigation time [ Time Frame: 3-month ]
    Time from endoscope insertion into patient's rectum till colonic lesion is reached (in minutes)

  2. Dissection time [ Time Frame: 3-month ]
    Time from the start of lesion removal till the lesion removal is completed (in minutes)

  3. Length of Hospital Stay [ Time Frame: 3-month ]
    Days of admission to the hospital post procedure till the patient is discharged from the hospital (in days)

  4. Cost of service [ Time Frame: 3-month ]
    Total financial cost (in USA dollars) of the medical care received pertaining to the procedure and related follow-up

  5. 30-day readmittance rate [ Time Frame: 30-day ]
    Number of patients readmitted to the hospital during first 30 days post colonoscopy

  6. Patient satisfaction survey [ Time Frame: 3-month ]
    Patients are given three statements regarding their procedures for which they answer if they agree or disagree with the statement.

  7. Histologic pathology summary [ Time Frame: 3-month ]
    The final pathological determination of the excised specimen, as determined by pathological examination

  8. Rate of complications [ Time Frame: 3-month ]
    Adverse effects that occur during the study



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men or women 18-85 years of age.
  2. Have ability to understand the requirements of the study and provide written informed consent
  3. Suspected complex adenomatous polyps in the large intestine defined as sessile or polypoid lesions 2 cm and larger in size.
  4. No medical contraindication to endoscopic submucosal dissection (ESD).

Exclusion Criteria:

  1. Contraindication to colonoscopy, such as active colitis, diverticulitis, perforation, or stricture.
  2. History of open or laparoscopic colorectal surgery.
  3. History of Inflammatory Bowel Disease (IBD).
  4. Any medical or surgical condition that would preclude the endoscopic removal of the polyp.
  5. 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.
  6. History of AIDS, HIV, or active hepatitis.
  7. 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.
  8. Patients who are pregnant or lactating.
  9. Currently involved in another investigational product for similar purposes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03846609


Locations
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United States, Maryland
Mercy Medical Center
Baltimore, Maryland, United States, 21202
Sponsors and Collaborators
Mercy Medical Center
Investigators
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Principal Investigator: Sergey V Kantsevoy, MD, PhD Director of The Therapeutic Endoscopy Mercy Medical Center
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Responsible Party: Sergey Kantsevoy, M.D., Ph.D., Director of Therapeutic Endoscopy, Mercy Medical Center
ClinicalTrials.gov Identifier: NCT03846609    
Other Study ID Numbers: 1368768-2
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: December 11, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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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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
Keywords provided by Sergey Kantsevoy, M.D., Ph.D., Mercy Medical Center:
Endoscopic Submucosal Dissection
Additional relevant MeSH terms:
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Colonic Polyps
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical