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High Volume Simethicone VCE Clinical Trial

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: NCT02334631
Recruitment Status : Completed
First Posted : January 8, 2015
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Michael Sai Lai Sey, MD, Lawson Health Research Institute

Brief Summary:
Video capsule endoscopy (VCE) is a procedure where a small camera is swallowed to examine the small bowel. Although the procedure is useful for diagnosing small bowel diseases, air bubbles can obscure the recorded images. Simethicone is a medication that can be used to disperse the air bubbles. However, prior studies using this medication have shown only a modest benefit. In our study, we would like to investigate whether increasing the amount of medication will improve the recorded images further.

Condition or disease Intervention/treatment Phase
Small Bowel Diseases Drug: High Volume Simethicone Drug: Standard Volume Simethicone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Double Blind Randomized Controlled Trial of High Volume Simethicone to Improve Visualization During Capsule Endoscopy
Actual Study Start Date : January 2017
Actual Primary Completion Date : August 2019
Actual Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Simethicone

Arm Intervention/treatment
Experimental: High volume simethicone
High volume simethicone is defined as 1125 mg simethicone in 750 ml of water (1.5 mg/ml).
Drug: High Volume Simethicone
High volume simethicone is defined as 1125 mg simethicone in 750 ml of water (1.5 mg/ml).

Active Comparator: Standard volume simethicone
Standard volume simethicone is defined as 300 mg simethicone in 200 ml of water (1.5 mg/ml).
Drug: Standard Volume Simethicone
Standard volume simethicone is defined as 300 mg simethicone in 200 ml of water (1.5 mg/ml).




Primary Outcome Measures :
  1. Visualization quality [ Time Frame: Once during review of capsule images ]
    Visualization quality will be scored in a blinded fashion using a validated score developed by Park et al. (World J Gastroenterol 2010;16(7):875-80.) Representative images from the small bowel will be serially selected at five-minute intervals. Each image is evaluated for two parameters: the proportion of visualized mucosa (VM) and degree of obscuration (DO) by bubbles, debris etc. The proportion of visualized mucosa is scored on a three- point scale: > 75% = 3, 50% to 75% = 2, 25% to 50% = 1, <25% = 0. The degree of obscuration is also scored in a three point scale: < 5 % = 3, 5% to 25% = 2, 25% to 50% = 1, > 50 % = 0. Mean scores for each parameter are obtained by dividing the sum of all images scored by the number of images. Finally the average of the two parameters is calculated. Both the whole, proximal, and distal small bowel will be scored separately. The first half of the small bowel will be considered proximal while the second half will be considered distal.


Secondary Outcome Measures :
  1. Visualized mucosa sub-score [ Time Frame: Once during review of capsule images ]
    The 'Visualized Mucosa' sub-score of the visualization quality score described above.

  2. Degree of obscuration sub-score [ Time Frame: Once during review of capsule images ]
    The 'Degree of Obstruction' sub-score of the visualization quality score described above.

  3. Diagnostic Yield [ Time Frame: Once during review of capsule images ]

    A.The study will be considered 'diagnostic' if a clinically relevant lesion is found.

    B. The lesion may be clinically related to the referral indication or incidental.

    C. Lesions will be classified into: angioectasia, ulceration, stricture, polyp, mass, or other.


  4. Study Completion Rate [ Time Frame: Once during review of capsule images ]
    Study will be considered complete if the capsule passes into the cecum.

  5. Gastric Emptying Time [ Time Frame: Once during review of capsule images ]
    Defined as the time from the first gastric image until the first duodenal image.

  6. Small Bowel Transit Time [ Time Frame: Once during review of capsule images ]
    Defined as the time from the first duodenum image until the first cecal image

  7. Adverse Events [ Time Frame: Once 7 days after the procedure. ]
    Adverse events will be defined as new abdominal pain, diarrhea, constipation, bloating, and other between 0-7 days after the procedure that is different than pre-existing symptoms.



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

Inclusion Criteria

1. Patients undergoing small bowel video capsule endoscopy

Exclusion Criteria

  1. Patients with a contraindication to VCE (small bowel strictures, oropharyngeal dysphagia, pregnancy, patients who are not surgical candidates)
  2. Endoscopic insertion of video capsule endoscope
  3. Inpatient procedures for active GI bleeding
  4. Patients with fluid restriction or who are unable to drink up to 900 ml of fluid within 10 minutes prior to the VCE

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): NCT02334631


Locations
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Canada, Ontario
London Health Sciences Centre- Victoria Campus
London, Ontario, Canada, N6A 5W9
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Michael SL Sey, MD London Health Sciences Centre
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Responsible Party: Michael Sai Lai Sey, MD, MD, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02334631    
Other Study ID Numbers: 7339
First Posted: January 8, 2015    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Simethicone
Antifoaming Agents
Molecular Mechanisms of Pharmacological Action
Emollients
Dermatologic Agents