Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Polyp Detection Rate After Single Oral Dose of Methylene Blue MMX Modified Release Tablets Administered to Subjects Undergoing Outpatients Colonoscopy

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: NCT01520337
Recruitment Status : Completed
First Posted : January 27, 2012
Last Update Posted : February 11, 2014
Sponsor:
Information provided by (Responsible Party):
CosmoTech ( Cosmo Technologies Ltd )

Tracking Information
First Submitted Date January 25, 2012
First Posted Date January 27, 2012
Last Update Posted Date February 11, 2014
Study Start Date January 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 26, 2012)
Polyp and adenoma detection rate [ Time Frame: 1 day ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01520337 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Polyp Detection Rate After Single Oral Dose of Methylene Blue MMX Modified Release Tablets Administered to Subjects Undergoing Outpatients Colonoscopy
Official Title Polyp Detection Rate After Single Oral Dose of Methylene Blue MMX Modified Release Tablets Administered to Subjects Undergoing Outpatients Colonoscopy
Brief Summary Polyp detection rate in colonoscopy following oral administration of MMX methylene blue tablets
Detailed Description Polyp detection rate in colonoscopy following oral administration of methylene blue MMX modified release tablets in subjects undergoing colonoscopy as outpatients.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
mucosal biopsy
Sampling Method Non-Probability Sample
Study Population patients scheduled for screening or surveillance colonoscopy.
Condition Polyp and Adenoma Detection During Colonoscopy
Intervention Device: oral tablet dye for detection of polyps during colonoscopy
oral tablet dye for improved detection of
Study Groups/Cohorts patients undergoing outpatient colonoscopy
Intervention: Device: oral tablet dye for detection of polyps during colonoscopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 10, 2014)
170
Original Estimated Enrollment
 (submitted: January 26, 2012)
100
Actual Study Completion Date October 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients scheduled for screening or surveillance colonoscopy. Written informed consent.Practising reliable contraception or sterile.Ability to understand and comply with the protocol.

Exclusion Criteria:

  • Pregnancy or lactation known or suspected hypersensitivity GI obstruction or perforation serious cardiovascular, renal or hepatic disease. reduced prothrombin time,elevated serum creatinine.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01520337
Other Study ID Numbers CB-17-01/05
2011-005694-23 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party CosmoTech ( Cosmo Technologies Ltd )
Study Sponsor Cosmo Technologies Ltd
Collaborators Not Provided
Investigators Not Provided
PRS Account CosmoTech
Verification Date February 2014