NCT02352233

Brief Summary

Colonoscopy is the "gold standard" technique for diagnosis and treatment of colonic lesions. Moreover, high definition colonoscopes (HD) associated to digital chromoendoscopy had shown better results regarding adenoma and polyps detection when compared to standard non HD scopes. However, evidence shows that during standard colonoscopy many lesions could be missed, including polyps, cancer and other kind of lesions. This could be correlated to many factors and recently reports show evidence that lesions behind the folds could be missed because the limitation of a forward view examination. Until know, a new auxiliary imaging device called "Third Eye Retroscope" had demonstrated more lesions detection during colonoscopy using a retro view, but with some limitations as absence of HD vision, the need of additional equipment and the fact the device occupies the accessory channel, limiting therapeutic efficiency. Recently a new HD colonoscope called "RETROVIEW" (PENTAX Medical) has been developed. It permits visualization of colonic mucosa in forward view, in retroflex view and allows for performance of diagnostic and therapeutics in a single colonoscope.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

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

Study Start

First participant enrolled

January 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 2, 2015

Completed
Last Updated

February 2, 2015

Status Verified

September 1, 2014

Enrollment Period

2 months

First QC Date

August 5, 2014

Last Update Submit

January 27, 2015

Conditions

Colonic Diseases

Keywords

retroview colonoscoperetroflexion colonoscopycolonoscopy

Outcome Measures

Primary Outcomes (2)

  • Safety

    The safety was measured by the number of cases with bleeding or perforation

    3 months

  • Feasibility

    The feasibility was measured determining the number of cases that was possible to perform a retro view by segments in the colon.

    3 months

Secondary Outcomes (2)

  • Withdrawal colonoscopy phase

    3 months

  • Total procedure time

    3 months

Other Outcomes (2)

  • Number of lesions

    3 months

  • Endoscopic Treatment

    3 months

Study Arms (1)

colonoscopy group

consecutive patients undergoing for colonoscopy for any formal indication. Patients were submitted to colonoscopy using RETROVIEW colonoscope

Procedure: RETROVIEW colonoscope

Interventions

RETROVIEW colonoscopePROCEDURE

withdrawal in retro vision and forward vision was performed by segments (right, transverse, left, sigmoid colon and rectum). Retroflexed therapeutics procedures were executed when needed.

Also known as: Retro view colonoscopy, Retroflexion during colonoscopy
colonoscopy group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

consecutive patients undergoing for colonoscopy at the Instituto Ecuatoriano de Enfermedades Digestivas

You may qualify if:

  • undergoing colonoscopy for colorectal neoplasia screening, for polyp surveillance, or for diagnostic workup including anemia, abdominal pain, constipation, abnormal imaging; and if they were able to understand and provide written consent for the procedure.

You may not qualify if:

  • age \<18; pregnancy, included history of colon resection, known inflammatory bowel disease, polyposis syndrome, radiation therapy to abdomen or pelvis, suspicion of chronic stricture potentially precluding complete colonoscopy, presence of diverticulitis or toxic megacolon, hemophilia and concurrent enrollment in another clinical investigation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Ecuatoriano de Enfermedades Digestivas

Guayaquil, Guayas, 1301266, Ecuador

Location

Related Publications (1)

  • Waye JD, Heigh RI, Fleischer DE, Leighton JA, Gurudu S, Aldrich LB, Li J, Ramrakhiani S, Edmundowicz SA, Early DS, Jonnalagadda S, Bresalier RS, Kessler WR, Rex DK. A retrograde-viewing device improves detection of adenomas in the colon: a prospective efficacy evaluation (with videos). Gastrointest Endosc. 2010 Mar;71(3):551-6. doi: 10.1016/j.gie.2009.09.043. Epub 2009 Dec 16.

    PMID: 20018280BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

biopsies, tissue from colonic mucosa: inflammatory, polyps

MeSH Terms

Conditions

Colonic Diseases

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Carlos Robles-Medranda, MD

    Instituto Ecuatoriano de Enfermedades Digestivas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2014

First Posted

February 2, 2015

Study Start

January 1, 2014

Primary Completion

March 1, 2014

Study Completion

April 1, 2014

Last Updated

February 2, 2015

Record last verified: 2014-09

Locations

EC(1)