NCT02859870

Brief Summary

The coloscopy is considered as the gold standard for screening and resection of colorectal adenomas. However the literature reports that the rate of omitted adenoma is still high (24 to 41%). The development of the FUSE system (Endochoice, USA) allows a larger field of view with a projection onto 3 screens (330° vision). A pilot study and a randomized multicentre has demonstrated the feasibility with a significant improvement of the rate of detected adenomas. This first study in France concerning this technology has the objectives to demonstrate the feasibility in France, the safety and to compare the rate of detected adenomas with data of the literature.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
141

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2015

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

March 18, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
Last Updated

August 21, 2017

Status Verified

August 1, 2017

Enrollment Period

1.1 years

First QC Date

August 2, 2016

Last Update Submit

August 16, 2017

Conditions

Colorectal Adenoma

Outcome Measures

Primary Outcomes (2)

  • Efficacy

    Cecal intubation rate

    1 day

  • Efficacy

    Absence of necessity to change of endoscope in case of progression, visualization, biopsy or resection

    1 day

Secondary Outcomes (1)

  • Toxicity

    1 day

Interventions

FUSE-TM colonoscopeDEVICE

Colonoscopy in conditions of normal security including patient clinical examination before leaving the hospital. Data collection by each operator.

Eligibility Criteria

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

Patient with colorectal adenoma candidate to colonoscopy of diagnostic

You may qualify if:

  • Age \>18 years
  • Diagnostic colonoscopy

You may not qualify if:

  • Colorectal cancer
  • Colic surgery
  • Preparation of average or poor quality
  • Rectal polyp of hyperplastic type \<2 mm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Paoli Cakmettes

Marseille, Bouches du Rhône, 13009, France

Location

Related Publications (5)

  • Gralnek IM, Segol O, Suissa A, Siersema PD, Carr-Locke DL, Halpern Z, Santo E, Domanov S. A prospective cohort study evaluating a novel colonoscopy platform featuring full-spectrum endoscopy. Endoscopy. 2013 Sep;45(9):697-702. doi: 10.1055/s-0033-1344395. Epub 2013 Aug 12.

    PMID: 23939509BACKGROUND

  • Gralnek IM, Siersema PD, Halpern Z, Segol O, Melhem A, Suissa A, Santo E, Sloyer A, Fenster J, Moons LM, Dik VK, D'Agostino RB Jr, Rex DK. Standard forward-viewing colonoscopy versus full-spectrum endoscopy: an international, multicentre, randomised, tandem colonoscopy trial. Lancet Oncol. 2014 Mar;15(3):353-60. doi: 10.1016/S1470-2045(14)70020-8. Epub 2014 Feb 20.

    PMID: 24560453BACKGROUND

  • Rex DK, Cutler CS, Lemmel GT, Rahmani EY, Clark DW, Helper DJ, Lehman GA, Mark DG. Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies. Gastroenterology. 1997 Jan;112(1):24-8. doi: 10.1016/s0016-5085(97)70214-2.

    PMID: 8978338BACKGROUND

  • Rex DK, Rahmani EY, Haseman JH, Lemmel GT, Kaster S, Buckley JS. Relative sensitivity of colonoscopy and barium enema for detection of colorectal cancer in clinical practice. Gastroenterology. 1997 Jan;112(1):17-23. doi: 10.1016/s0016-5085(97)70213-0.

    PMID: 8978337BACKGROUND

  • Siersema PD, Rastogi A, Leufkens AM, Akerman PA, Azzouzi K, Rothstein RI, Vleggaar FP, Repici A, Rando G, Okolo PI, Dewit O, Ignjatovic A, Odstrcil E, East J, Deprez PH, Saunders BP, Kalloo AN, Creel B, Singh V, Lennon AM, DeMarco DC. Retrograde-viewing device improves adenoma detection rate in colonoscopies for surveillance and diagnostic workup. World J Gastroenterol. 2012 Jul 14;18(26):3400-8. doi: 10.3748/wjg.v18.i26.3400.

    PMID: 22807609BACKGROUND

Study Officials

  • Jean-Philippe RATONE, MD

    Institut Paoli-Calmettes

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 2, 2016

First Posted

August 9, 2016

Study Start

March 18, 2015

Primary Completion

April 30, 2016

Study Completion

April 30, 2016

Last Updated

August 21, 2017

Record last verified: 2017-08

Locations

FR(1)