Adenoma Detection Rate Using Endocuff Vision in China

NCT03839277 | Suspended

• 1 other identifier: SINOCOLO2019A
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 5

Brief Summary

The primary aim of this study is \- to explore the usefulness of Endocuff Vision in colonoscopy on adenoma detection rate (ADR). Other aims include to explore the data below when Endocuff Vision is used. Mean adenomas detected per procedure, MAP Proximal Adenoma detection rate, pADR Polyp detection rate, PDR Proximal polyp detection rate, pPDR Mean polyps detected per procedure, MPP Withdrawal time, WT Cecal intubation rate, CIR Cecal intubation time, CIT

Conditions

Colorectal Neoplasms; Colonic Polyp; Adenoma

Keywords

adenoma detection rate

Outcome Measures

Primary Outcomes (1)

• Adenoma detection rate, ADR

  ADR refer to the rate of adenoma detection, calculated as the proportion of subjects with at least one adenoma.

  At the end of the procedure, up to 1 hour.

Secondary Outcomes (1)

• Polyp detection rate, PDR

  At the end of the procedure, up to 1 hour.

Study Arms (2)

Endocuff Vision-assisted Colonoscopy

ACTIVE COMPARATOR

Participants in this arm undergo Endocuff Vision-assisted colonoscopy

Device: Endocuff Vision

Standard Colonoscopy

NO INTERVENTION

Participants in this arm undergo standard colonoscopy

Interventions

Endocuff Vision DEVICE

Endocuff Vision is attached to the tip of colonoscope before intubation.

Endocuff Vision-assisted Colonoscopy

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients referred for screening, surveillance, or diagnostic colonoscopy
• All patients must be able to give informed consent

You may not qualify if:

• Patients with any absolute contraindications to colonoscopy
• Patients with established or suspicion of large bowel obstruction or pseudo-obstruction
• Patients with known colon cancer or polyposis syndromes
• Patients with known colonic strictures
• Patients with known severe diverticular segments (that is likely to impede colonoscope passage)
• Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)
• Patients lacking capacity to give informed consent
• Pregnancy
• Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure.
• Patients who are attending for a therapeutic procedure or assessment of a known lesion

Sponsors & Collaborators

• Changhai Hospital: lead
• Sixth Affiliated Hospital, Sun Yat-sen University: collaborator
• Shanghai Zhongshan Hospital: collaborator
• Tianjin People's Hospital: collaborator
• Tianjin Nankai Hospital: collaborator

Study Sites (5)

Sixth affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510655, China

Location

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Tianjin Nankai Hospital

Tianjin, Tianjin Municipality, 300100, China

Location

Tianjin People's Hospital

Tianjin, Tianjin Municipality, 300121, China

Location

Related Publications (1)

• Ngu WS, Bevan R, Tsiamoulos ZP, Bassett P, Hoare Z, Rutter MD, Clifford G, Totton N, Lee TJ, Ramadas A, Silcock JG, Painter J, Neilson LJ, Saunders BP, Rees CJ. Improved adenoma detection with Endocuff Vision: the ADENOMA randomised controlled trial. Gut. 2019 Feb;68(2):280-288. doi: 10.1136/gutjnl-2017-314889. Epub 2018 Jan 23.

  PMID: 29363535 BACKGROUND

Related Links

• PubMed link

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Polyps; Adenoma

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• En-Da YU

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Colorectal Surgery and Vice Director of GI Endoscopy

Model Details: Endocuff Vision is a new device made of soft plastic material with a unique dynamic shape. It is manufactured by ARC Medical Design Limited and Diagmed in the United Kingdom. It has European Conformity in United Kingdom. The core is made of polypropylene and the 'finger like' projections are made of a thermoplastic elastomer. It comes in four colour coded sizes (purple, blue, green and orange) to fit a range of paediatric and adult colonoscopes. Endocuff Vision is the more updated version of device that has only one proximal row of more rounded finger-like projections. It is mounted at the tip of the colonoscope and held on by friction (pull-off force is a minimum of 10 Newtons).

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 15, 2019
• Study Start: June 12, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 28, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)