Effectiveness and Safety of the Colonoscopy With "Visualization" Balloon

NCT02117232 | Completed DMC

• 1 other identifier: VB-001
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Adenomatous Polyps

Keywords

colonoscopy; cecal intubation; carbon dioxide insufflation

Outcome Measures

Primary Outcomes (1)

• Cecal intubation time

  Time required to reach cecum

  Immediately

Secondary Outcomes (5)

• Length of colonoscope when it reaches cecum

  Immediately

• Ease of colonoscope insertion

  Immediate

• Dose of analgesics and sedatives used

  Immediately

• Patient satisfaction

  Immediately and in 24 hours

• Total procedure time

  Immediately

Other Outcomes (1)

• Amount of carbon dioxide used

  Immediately

Study Arms (2)

Visualization balloon

EXPERIMENTAL

Colonoscopy performed with the use of "Visualization" balloon

Device: Visualization balloon

Traditional CO2-insufflation colonoscopy

ACTIVE COMPARATOR

Traditional colonoscopy performed with CO2 insufflation without "Visualization" balloon

Device: Traditional CO2 insufflation colonoscopy

Interventions

Visualization balloon 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.

Visualization balloon

Traditional CO2 insufflation colonoscopy DEVICE

Traditional colonoscopy performed with CO2 insufflation without "Visualization" balloon

Traditional CO2-insufflation colonoscopy

Eligibility Criteria

• Age: 17 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is undergoing colonoscopy for colo-rectal cancer screening, polypectomy or for diagnostic workup.
• 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.)
• Age from 17 to 90 years.
• Be willing and able to comply with the requirements of the protocol.
• Be willing to refrain from participating in any other investigational interventional study while enrolled in this study.
• 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.

You may not qualify if:

• Subjects with a history of previous colonic resection.
• Subjects with uncorrectable bleeding disorders (INR more than 1.5, platelet count less than 50,000).
• Subjects unwilling or unable to give written consent to participate in the investigation or unable to comply with the requirements of the protocol.
• Subjects with suspected colonic strictures potentially precluding complete colonoscopy.
• Subjects who received any experimental drug or device within the previous three months.
• 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.
• 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.

Sponsors & Collaborators

• Mercy Medical Center: lead

Study Sites (1)

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

Study Officials

• Sergey V Kantsevoy, MD, PhD

  Mercy Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Therapeutic Endoscopy Mercy Medical Center, Clinical Professor of Medicine University of Maryland School of Medicine

Study Record Dates

• First Submitted: April 11, 2014
• First Posted: April 17, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 21, 2018

Record last verified: 2018-08

Locations

US (1)