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Colonoscope Insertion Trial Protocol

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ClinicalTrials.gov Identifier: NCT01324882
Recruitment Status : Completed
First Posted : March 29, 2011
Results First Posted : August 23, 2013
Last Update Posted : December 2, 2017
Sponsor:
Information provided by (Responsible Party):
Joseph Anderson, UConn Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Diagnostic
Condition Colorectal Cancer
Interventions Device: Colonoscopy with Olympus Technically Improved Colonoscope
Device: Control with standard colonoscope Olympus CF-H180
Enrollment 57
Recruitment Details Patients were recruited from study initiation 1/31/2011 until June 30,2011. Patients were recruited from the clinic.
Pre-assignment Details No details to report
Arm/Group Title Study Arm Control
Hide Arm/Group Description This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope. This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.
Period Title: Overall Study
Started 27 [1] 30 [2]
Completed 27 [3] 30 [4]
Not Completed 0 0
[1]
27 patients were randomized to this arm.
[2]
30 patients were randomized to this arm
[3]
27 patients had the colonoscopy
[4]
30 patients had the colonoscopy
Arm/Group Title Study Arm Control Total
Hide Arm/Group Description This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope. This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180. Total of all reporting groups
Overall Number of Baseline Participants 27 30 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 30 participants 57 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
  92.6%
25
  83.3%
50
  87.7%
>=65 years
2
   7.4%
5
  16.7%
7
  12.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 30 participants 57 participants
55.7  (6.8) 56  (8.3) 55.85  (7.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 30 participants 57 participants
Female
12
  44.4%
13
  43.3%
25
  43.9%
Male
15
  55.6%
17
  56.7%
32
  56.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 30 participants 57 participants
27 30 57
1.Primary Outcome
Title Time to Intubate the Cecum
Hide Description The time in seconds that it required to intubate the cecum as defined in our protocol.
Time Frame The outcome was measured during the colonoscopy which was Day 1. The duration of the study was the colonoscopy on Day 1. Once the colonoscopy was finished, the study was over.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Arm Control
Hide Arm/Group Description:
This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.
This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.
Overall Number of Participants Analyzed 27 30
Mean (Standard Deviation)
Unit of Measure: seconds
271  (196) 403  (148)
2.Primary Outcome
Title Intubation of Cecum
Hide Description The ability of endoscopist to intubate the cecum with enough control of the tip to abut the appendix or begin to retroflex in the cecum.
Time Frame (day 1) Within time for performance of colonoscopy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Arm Control
Hide Arm/Group Description:

This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.

Colonoscopy with Olympus Technically Improved Colonoscope: The standard colonoscopy will be performed using the Olympus Technically Improved Colonoscope.

This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.

Control with standard colonoscope Olympus CF-H180: Standard colonoscopy using the adult scope, Olympus CF-H180.

Overall Number of Participants Analyzed 27 30
Measure Type: Count of Participants
Unit of Measure: Participants
27
 100.0%
29
  96.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study Arm, Control
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame An Average of 20 minutes, up to 30 minutes post procedure.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Study Arm Control
Hide Arm/Group Description This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope. This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.
All-Cause Mortality
Study Arm Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Study Arm Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Study Arm Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/30 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Joseph Anderson
Organization: UConn Health Center
Phone: 8022959362 ext 6003
EMail: joseph.anderson@dartmouth.edu
Layout table for additonal information
Responsible Party: Joseph Anderson, UConn Health
ClinicalTrials.gov Identifier: NCT01324882     History of Changes
Other Study ID Numbers: 10-246-1
1-642-01 ( Other Identifier: UCHC )
First Submitted: March 24, 2011
First Posted: March 29, 2011
Results First Submitted: May 8, 2013
Results First Posted: August 23, 2013
Last Update Posted: December 2, 2017