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Accuracy of Endoscopists in Predicting Polyp Pathology

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ClinicalTrials.gov Identifier: NCT03477318
Recruitment Status : Completed
First Posted : March 26, 2018
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
TriHealth Inc.

Tracking Information
First Submitted Date March 20, 2018
First Posted Date March 26, 2018
Last Update Posted Date June 14, 2019
Actual Study Start Date March 20, 2018
Actual Primary Completion Date November 7, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 20, 2018)
Polyp prediction accuracy [ Time Frame: up to 5 days ]
Accuracy of predicting polyp type
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03477318 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 Accuracy of Endoscopists in Predicting Polyp Pathology
Official Title Accuracy of Endoscopists in Predicting Polyp Pathology
Brief Summary The study purpose is to assess the accuracy of experienced endoscopists at a community hospital in predicting histological types of polyps resected at colonoscopy using white light. Patients 50 years or older undergoing first-time screening colonoscopy will be included in this observational study.
Detailed Description The study purpose is to assess the accuracy of experienced endoscopists at a community hospital in predicting histological types of polyps resected at colonoscopy using white light. The study will be conducted at Good Samaritan Hospital and TriHealth Surgery Center West. Study participants include patients 50 years or older undergoing first-time screening colonoscopy. This is an observational study and does not involve any patient interventions. After completing the colonoscopy, the endoscopist will document their prediction of the polyp type. The polyp type predicted by the endoscopist will be compared to the polyp type documented in the pathology report to determine accuracy. It is estimated that study enrollment will take 6 months.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients 50 years or older undergoing first-time screening colonoscopy
Condition Resected Polyp
Intervention Not Provided
Study Groups/Cohorts Patients undergoing screening colonoscopy
Patients undergoing first-time colonoscopy using white light with at least 1 polyp resected.
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: June 12, 2019)
159
Original Estimated Enrollment
 (submitted: March 20, 2018)
120
Actual Study Completion Date November 7, 2018
Actual Primary Completion Date November 7, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Males and females

Exclusion Criteria:

  • first degree relative diagnosed with colorectal carcinoma at age 59 or under
  • New onset of iron deficiency anemia (within past 3 months)
  • Abnormal imaging of colon within past 3 months
  • Pregnant women
  • Inadequate visualization reported by endoscopist
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03477318
Other Study ID Numbers 17-075
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party TriHealth Inc.
Study Sponsor TriHealth Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account TriHealth Inc.
Verification Date May 2018