Post Market Evaluation of Aer-O-Scope Visualization

NCT02926209 | Terminated Results DMC FDA Device

• 1 other identifier: 934CLD
• Study Type: interventional
• Target: 104
• Locations: 2 countries
• Sites: 2

Brief Summary

This will be a prospective multi-center, multi-national comparative non-blinded clinical investigation. Each subject will undergo back-to-back tandem colonoscopies with the Aer-O-Scope Colonoscope System and a conventional colonoscope since this is a tandem colonoscopy study, each subject will serve as their own control. The 1st procedure will be randomized, half to Aer-O-Scope Colonoscope System and half to conventional colonoscope. The same investigator will perform both procedures on each subject. All pathologies found will be either removed or tattooed. Unmarked pathologies found on second pass will represent those missed during the 1st pass, thus making the subject and the control one and the same. Tattooed pathologies that can be removed endoscopically will be removed in an additional colonoscopy. This may occur if a large polyp cannot be removed for any reason with the Aer-O-Scope, but can be removed with conventional colonoscopy.

Conditions

Cancer

Keywords

colonoscopy; adenoma; polyp; crc screening

Outcome Measures

Primary Outcomes (1)

• Adenoma Miss Rates

  Determined by second pass colonoscopy - lesions detected in second pass represent lesions missed during first pass - adenomatic status based on histopathology. Three (3) lesions were missed by the Aer-OScope and detected with the subsequent conventional colonoscopy. Two (2) polyps were not removed and an additional one (1) was not retrieved. Data was missing for two (2) lesions by the Conventional Colonoscopy (CC)

  Through study completion, an average of one year

Secondary Outcomes (2)

• Polyp Miss Rates (PMR) for Each Study Arm

  Through study completion, an average of one year

• Advanced Adenoma Miss Rates (AAMR) for Each Study Arm

  Through study completion, an average of one year

Study Arms (2)

Aer-O-Scope First

ACTIVE COMPARATOR

Patients in this arm will undergo colonoscopy using the Aer-O-Scope followed by colonoscopy using a conventional colonoscope

Device: Aer-O-Scope (Colonoscopy); Procedure: Colonoscopy (Conventional Colonoscope)

Conventional Colonoscope First

ACTIVE COMPARATOR

Patients in this arm will undergo colonoscopy using a conventional colonoscope followed by colonoscopy using the Aer-O-Scope

Device: Aer-O-Scope (Colonoscopy); Procedure: Colonoscopy (Conventional Colonoscope)

Interventions

Aer-O-Scope (Colonoscopy) DEVICE

Patients in the "Aer-O-Scope first arm" will undergo a colonoscopy with the Aer-O-Scope, removing any polyps detected, followed by a colonoscopy using a conventional colonoscope, removing any polyps not previously detected with the Aer-O-Scope.

Also known as: CRC Screening

Aer-O-Scope First; Conventional Colonoscope First

Colonoscopy (Conventional Colonoscope) PROCEDURE

Patients in the "conventional colonoscope first arm" will undergo a colonoscopy with a conventional colonoscope, removing any polyps detected, followed by a colonoscopy using the Aer-O-Scope, removing any polyps not previously detected with the conventional colonoscope

Also known as: CRC Screening

Aer-O-Scope First; Conventional Colonoscope First

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is indicated for screening, diagnostic (minor complaints such as rectal bleeding or minor abdominal pain) or surveillance colonoscopy
• Subject willing to undergo tandem colonoscopies with Aer-O-Scope Colonoscope and a conventional colonoscope (including a single colon preparation bowel cleansing)
• Subject between the ages of 45 and 75 (patients between the ages of 45 and 50 must have a family history of a first degree relative with onset of colon cancer before the age of 60).
• Subject is able to understand and willing to sign informed consent form

You may not qualify if:

• Personal history of colorectal neoplasia including familial adenomatous polyposis or hereditary nonpolyposis, colon cancer (HNPCC).
• Diagnosis of active (flaring) inflammatory bowel disease (active ulcerative colitis or Crohn's colitis), bowel obstruction, or acute diverticulitis, or known severe diverticulosis, fecal incontinence or any known large-bowel disease that would require a predetermined therapeutic colonoscopy (non-screening, non-diagnostic or non-surveillance cases)
• Severe gastrointestinal tract-related symptoms, or complaints, suggesting performance of a pre-determined therapeutic colonoscopy (non-screening, non-diagnostic or non-surveillance cases)
• History of colonic resection
• Clinically significant cardiovascular or pulmonary disease.
• Cancer or other life threatening disease or significant chronic condition that puts the subject at risk.
• Blood-clotting disorders and/or current anticoagulant therapy (Subjects taking up to 100mg aspirin for prophylactic treatment are acceptable for this study)
• Pregnancy
• Previous radiation therapy to the abdomen
• Morbid Obesity (BMI \> 40 kg/m2)
• Drug abuse or alcoholism
• Subject is bed-ridden and/or unable to adequately communicate
• Subject is under custodial care
• Subject has a history of psychiatric disorders which would prevent compliance with study instructions
• Participation in a clinical study within the previous 30 days

Sponsors & Collaborators

• GI View Ltd.: lead

Study Sites (2)

Waldron Endoscopy Center

Tacoma, Washington, 98405, United States

Location

Tel Aviv Souraski Medical Center

Tel Aviv, 6423906, Israel

Location

MeSH Terms

Conditions

Neoplasms; Adenoma; Polyps

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: CEO, Dr. Tal Simchony
• Organization: GI View Ltd.

tal@giview.com

+97235753199

Study Officials

• Erwin Santo, MD

  Tel Aviv Souraski Medical Center, Israel

  PRINCIPAL INVESTIGATOR

• Klaus Mergener, MD, PhD, MBA

  Waldron Endoscopy Center, Tacoma, WA, USA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2016
• First Posted: October 6, 2016
• Study Start: February 21, 2017
• Primary Completion: November 8, 2017
• Study Completion: April 11, 2018
• Last Updated: July 16, 2019
• Results First Posted: July 16, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1); US (1)