Effectiveness and Safety of the Colonoscopy With "Visualization" Balloon

NCT ID: NCT02117232

Last Updated: 2018-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2017-12-31

Brief Summary

Colonoscopy has become the "gold standard" in detection of colonic polyps and colon cancer. However, colonoscopy causes significant abdominal discomfort and abdominal pain during and after the procedure, requiring intravenous sedation and use of analgesics. The discomfort and pain are mostly caused by air insufflation and intubation difficulties during advancement of the colonoscope in order the reach the cecum.

Study Hypothesis: Use of the "Visualization" Balloon will facilitate advancement of the colonoscope and will eliminate the need for colonic distention with the air or CO2, which can shortened the length of the procedure, reduce patient's discomfort and can decrease amount of sedatives and analgesics used during colonoscopy.

Detailed Description

The goal of this study is to evaluate effectiveness and safety of a "Visualization" Balloon for performance of colonoscopy.

Our hypothesis is that, use of "Visualization" Balloon will decrease colonic distention, patient's discomfort, use of sedatives and analgetics during procedure and will simplify the performance of colonoscopy resulting in shortening of procedure time and increasing the rate of cecal intubation.

Specific aims of the study:

1. To compare procedure time and effectiveness of the "Visualization" Balloon colonoscopy with traditional CO2-insufflation colonoscopy.

2. To compare safety profiles between traditional CO2-insufflation colonoscopy and colonoscopy using the "Visualization" Balloon.

4 STUDY ENDPOINTS 4.1 Primary Outcome To compare the mean cecal intubation time achieved with "Visualization" Balloon colonoscopy, with the mean cecal intubation time achieved with standard colonoscopy using CO2 insufflation.

4.2 Secondary Outcomes

To compare "Visualization" Balloon colonoscopy with standard CO2-insufflation colonoscopy in regards of:

1. Total amount of carbon dioxide (CO2) gas for colonic insufflation used during the procedure.

2. Ease of colonoscope insertion.

3. The length of the colonoscope when it reaches the cecum. 4 Colonoscope withdrawal time and total procedure time.

5. Cecal intubation rate. 6. Total dosage of analgesics and sedative during procedure. 7. Patient satisfaction: perceived pain and discomfort immediately after the procedure and in 24 hours post procedure.

8. Complications during and after colonoscopy. 9. Polyp detection rate.

Conditions

Colonic Adenomatous Polyps

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Visualization balloon

Colonoscopy performed with the use of "Visualization" balloon

Group Type: EXPERIMENTAL

Visualization balloon

Intervention Type: DEVICE

The "Visualization" Balloon is a disposable medical device that is used during the advancement of the colonoscope inside the colon. The intended use of the "Visualization" Balloon is to help insertion of the colonoscope into the colon without the aid of gas (air or CO2) insufflation as with standard colonoscopy. The "Visualization" Balloon is inserted through the biopsy channel of the colonoscope prior to the colonoscope introduction into the rectum. The "Visualization" Balloon is an inflatable balloon that opens up the lumen of the gastrointestinal tract, thereby allowing the endoscopist to advance the endoscope inside and to view the gastrointestinal tract through the clear balloon.

Traditional CO2-insufflation colonoscopy

Traditional colonoscopy performed with CO2 insufflation without "Visualization" balloon

Group Type: ACTIVE_COMPARATOR

Traditional CO2 insufflation colonoscopy

Intervention Type: DEVICE

Traditional colonoscopy performed with CO2 insufflation without "Visualization" balloon

Interventions

Visualization balloon

The "Visualization" Balloon is a disposable medical device that is used during the advancement of the colonoscope inside the colon. The intended use of the "Visualization" Balloon is to help insertion of the colonoscope into the colon without the aid of gas (air or CO2) insufflation as with standard colonoscopy. The "Visualization" Balloon is inserted through the biopsy channel of the colonoscope prior to the colonoscope introduction into the rectum. The "Visualization" Balloon is an inflatable balloon that opens up the lumen of the gastrointestinal tract, thereby allowing the endoscopist to advance the endoscope inside and to view the gastrointestinal tract through the clear balloon.

Intervention Type: DEVICE

Traditional CO2 insufflation colonoscopy

Traditional colonoscopy performed with CO2 insufflation without "Visualization" balloon

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. The patient is undergoing colonoscopy for colo-rectal cancer screening, polypectomy or for diagnostic workup.

2. Subject is able to understand the risks and benefits of participating in the study and must be willing to sign and date the Informed Consent Form for this study approved by the Institutional Review Board (IRB.)

3. Age from 17 to 90 years.

4. Be willing and able to comply with the requirements of the protocol.

5. Be willing to refrain from participating in any other investigational interventional study while enrolled in this study.

6. Female subjects must have a negative pregnancy test within the last 24 hours timeline and have no intentions of becoming pregnant during participation in the study, or be sterilized.

Exclusion Criteria

1. Subjects with a history of previous colonic resection.

2. Subjects with uncorrectable bleeding disorders (INR more than 1.5, platelet count less than 50,000).

3. Subjects unwilling or unable to give written consent to participate in the investigation or unable to comply with the requirements of the protocol.

4. Subjects with suspected colonic strictures potentially precluding complete colonoscopy.

5. Subjects who received any experimental drug or device within the previous three months.

6. Female subjects who were pregnant or lactating or were intending to become pregnant during the period of the study, or who would not use an adequate method of contraception (contraceptive pill, intra-uterine device) for the duration of the study.

7. Subjects who possessed any psychological condition, or were under treatment for any condition which, in the opinion of the Investigator and/or consulting physicians(s), would constitute an unwarranted risk.

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mercy Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sergey Kantsevoy

Director of Therapeutic Endoscopy Mercy Medical Center, Clinical Professor of Medicine University of Maryland School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sergey V Kantsevoy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mercy Medical Center

Locations

Mercy Medical Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

VB-001

Identifier Type: -

Identifier Source: org_study_id