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Completed

NCT Number: NCT03846609

Evaluation of a Double Balloon Interventional Platform (DiLumen) for 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.

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Key information

Conditions

Colonic Polyp Colonic Polyps Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Total case time

    Time frame: 3-month

    Time from the beginning of procedure until the end of the entire procedure Iin minutes)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mercy Medical Center

Other

Registry information

Official study title

A Randomized Controlled Study Evaluating the Performance of a Double Balloon Interventional Platform (DiLumen) for Facilitating Complex Colonic ESD

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 19, 2019
Registry last updated
Dec 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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