Clinical Trials Logo
  1. Home
  2. Colonoscopy
  3. NCT03758872
  4. Details
NCT03758872 Clinical Trial

CUFF-assisted Colonoscopy vs Standard Colonoscopy

Colonoscopy Clinical Trial

— CUFF-TROCADERO  

Official title:
USE OF ENDOCUFF SECOND GENERATION IN THE COLIC POLYPS DETECTION: HISTORIC COHORTE PROSPECTIVE COMPARATIVE

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03758872
Other study ID # 2018-A01397-48
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 25, 2018
Est. completion date September 26, 2019

Study information
Verified date October 2018
Source Clinique du Trocadéro
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this study is to evaluate the interest of second-generation Endocuff Vision (ECV) to improve Adenoma detection rate and / or Polyp detection rate in routine colonoscopy. This is a prospective comparative cohort, on 1034 patients, 517 patients with ECV in prospective group and 517 without ECV in retrospective group

Recruitment information / eligibility
Status Completed
Enrollment 1034
Est. completion date September 26, 2019
Est. primary completion date September 26, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient scheduled for total colonoscopic exploration, during the period study - Patient over or equal to 18 years - ASA 1, ASA 2, ASA 3 - No participation in another clinical study - Certificate of non opposition signed Exclusion Criteria: - Patient under 18 years old - ASA 4, ASA 5 - Pregnant woman - Patient with coagulation abnormalities preventing polypectomy: prothrombin level <50%, -Platelets <50000 / mm3, effective anti-coagulation in progress, clopidogrel in progress. - Inflammatory bowel disease - Known colonic stenosis - Diverticulitis less than 6 weeks old - Patient unable to give consent or protected by law - Opposition expressed for inclusion in the study

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• cuff assisted colonoscopy(with cuff use of endocuff vision second generation)
this is a cohort prospective comparative, a group without cuff in 2017, 517 patient included in the retrospective phase, and in 2018, 517 patient will be included in the prospective phase with CUFF for detecting polyps

Locations
Country Name City State
France Clinique Du Trocadero Paris

Sponsors (1)
Lead Sponsor Collaborator
Clinique du Trocadéro

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary detection of polyp or adenoma with cuff during procedure
Secondary POLYP DETECTION RATE during procedure
Secondary morbidity : perforation rate 21 DAYS AFTER PROCEDURE
Secondary CAECAL INTUBATION RATE DURING PROCEDURE
Secondary TIME TO REACH CAECUM SEC DURING PROCEDURE
Secondary WITHDRAWAL TIME SEC DURING PROCEDURE
See also
  Status Clinical Trial Phase
Completed NCT04101097 - Training and Validation of Models of Factors to Predict Inadequate Bowel Preparation Colonoscopy
Completed NCT03247595 - Testing How Well Magnesium Citrate Capsules Work as Preparation for a Colonoscopy N/A
Completed NCT04214301 - An Open-Label Preference Evaluation of BLI800 Phase 4
Withdrawn NCT05754255 - Comparison of High-flow Oxygen With or Without Nasal Positive Airway Pressure (PAP) During Propofol Sedation for Colonoscopy in an Ambulatory Surgical Center N/A
Recruiting NCT02484105 - Comforting Conversation During Colonoscopy: A Trial on Patient Satisfaction Phase 4
Active, not recruiting NCT02264249 - Residual Gastric Volume in Same Day Versus Split Dose and Evening Before Bowel Preparation N/A
Completed NCT01964417 - The Comparative Study Between Bowel Preparation Method Phase 3
Terminated NCT01978509 - The Affect of Low-Volume Bowel Preparation for Hospitalized Patients Colonoscopies N/A
Recruiting NCT01685970 - Comparison of Same-day 2 Sachets Picosulfate Versus High Volume PEG for Afternoon Colonoscopy Phase 3
Completed NCT01518790 - Short Course, Single-dose PEG 3350 for Colonoscopy Prep in Children N/A
Recruiting NCT00748293 - Achievement of Better Examinee Compliance on Colon Cleansing Using Commercialized Low-Residue Diet N/A
Completed NCT00779649 - MoviPrep® Versus HalfLytely®, Low-VolUme PEG Solutions for Colon Cleansing: An InvesTigator-blindEd, Randomized, Trial Phase 4
Completed NCT00671177 - Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique N/A
Completed NCT00380497 - Pico-Salax Versus Poly-Ethylene Glycol for Bowel Cleanout Before Colonoscopy in Children Phase 4
Recruiting NCT00160823 - Impact of a Self-Administered Information Leaflet on Adequacy of Colonic Cleansing for in-Hospital Patients Phase 3
Completed NCT00314418 - Patient Position and Impact on Colonoscopy Time N/A
Completed NCT00390598 - PEG Solution (Laxabon®) 4L Versus Senna Glycoside (Pursennid® Ex-Lax) 36mg and PEG Solution (Laxabon®) 2L for Large Bowel Cleansing Prior to Colonoscopy Phase 2/Phase 3
Completed NCT00427089 - Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening Phase 3
Completed NCT00209573 - A Study of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Patients Undergoing Elective Colonoscopy Phase 3
Completed NCT05823350 - The Effect of Abdominal Massage on Pain and Distention After Colonoscopy N/A