NCT02334631

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2017

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2015

Completed
2 years until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

January 9, 2020

Status Verified

January 1, 2020

Enrollment Period

2.6 years

First QC Date

January 6, 2015

Last Update Submit

January 7, 2020

Conditions

Small Bowel Diseases

Outcome Measures

Primary Outcomes (1)

  • Visualization quality

    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.

    Once during review of capsule images

Secondary Outcomes (7)

  • Visualized mucosa sub-score

    Once during review of capsule images

  • Degree of obscuration sub-score

    Once during review of capsule images

  • Diagnostic Yield

    Once during review of capsule images

  • Study Completion Rate

    Once during review of capsule images

  • Gastric Emptying Time

    Once during review of capsule images

  • +2 more secondary outcomes

Study Arms (2)

High volume simethicone

EXPERIMENTAL

High volume simethicone is defined as 1125 mg simethicone in 750 ml of water (1.5 mg/ml).

Drug: High Volume Simethicone

Standard volume simethicone

ACTIVE COMPARATOR

Standard volume simethicone is defined as 300 mg simethicone in 200 ml of water (1.5 mg/ml).

Drug: Standard Volume Simethicone

Interventions

High Volume SimethiconeDRUG

High volume simethicone is defined as 1125 mg simethicone in 750 ml of water (1.5 mg/ml).

High volume simethicone
Standard Volume SimethiconeDRUG

Standard volume simethicone is defined as 300 mg simethicone in 200 ml of water (1.5 mg/ml).

Standard volume simethicone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Patients undergoing small bowel video capsule endoscopy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre- Victoria Campus

London, Ontario, N6A 5W9, Canada

Location

Related Publications (1)

  • Sey M, Yan B, McDonald C, Segal D, Friedland J, Puka K, Jairath V. A randomized controlled trial of high volume simethicone to improve visualization during capsule endoscopy. PLoS One. 2021 Apr 1;16(4):e0249490. doi: 10.1371/journal.pone.0249490. eCollection 2021.

    PMID: 33793636DERIVED

Study Officials

  • Michael SL Sey, MD

    London Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 6, 2015

First Posted

January 8, 2015

Study Start

January 1, 2017

Primary Completion

August 1, 2019

Study Completion

October 1, 2019

Last Updated

January 9, 2020

Record last verified: 2020-01

Locations

CA(1)