Extra Wide Field of View Lens Study

NCT06483503 | Active Not Recruiting FDA Device

• 1 other identifier: CA-PE-EFOV-2024-001 - V1.0
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observation study is to learn about the feasibility of a new colonoscope which provides the physician an extra-wide field of view during a screening colonoscopy. The main question this study aims to answer is can this new type of colonoscope locate polyps during clinical use in patients. Patients will undergo a routine colonoscopy for colorectal cancer or polyp surveillance and have one follow-up phone call up to 2 weeks of the colonoscopy.

Conditions

Colonic Polyp

Outcome Measures

Primary Outcomes (1)

• Cecal Intubation Rate

  The proportion of procedures in which the cecum was reached.

  Day 1

Secondary Outcomes (7)

• Procedure Time

  Day 1

• Ileum Intubation Rate

  Day 1

• Therapeutic Intervention Success Rate

  Day 1

• Mean number of polyps per coloscopy and its detection rate

  Day 1

• Mean number of adenomas and its detection rate

  Day 14

Interventions

EFOV Colonoscope DEVICE

Routine colonoscopy using the EFOV lens in the colonoscope.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults scheduled for screening colonoscopies, evaluation of a positive stool test or polyp surveillance colonoscopy.

You may qualify if:

• Screening for colorectal cancer at the age greater than or equal to 50 years, or evaluation of a positive stool test (i-FOBT) or polyp surveillance.
• Signed informed consent.

You may not qualify if:

• ASA classification ≥3.
• Age \<18 years.
• Known or suspicion of inflammatory bowel disease.
• Known polyp(s) for polypectomy.
• High risk for colorectal cancer, history of extensive polyposis, patients with known genetic disease.
• Prior colorectal surgery.
• Vulnerable subjects or subjects unable to follow the procedures of the investigation, e.g., due to language problems.
• Unable or unwilling to undergo bowel cleansing for colonoscopy.
• Female patients who are pregnant or nursing.
• Participation in another clinical trial within 30 days prior to the Screening Visit or during this study.

Sponsors & Collaborators

• Pentax Medical: lead

Study Sites (1)

RKM 740 Interdisciplinary Care Clinic - Gastroenterology

Düsseldorf, Germany

Location

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Horst Neuhaus, MD, PhD

  RKM 740 Interdisciplinary Specialist Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: July 3, 2024
• Study Start: August 21, 2024
• Primary Completion: December 8, 2024
• Study Completion: March 30, 2025
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)