Safety and Efficacy of the NaviAid™ G-Eye System During Colonoscopy

NCT01749722 | Completed

• 1 other identifier: G-Eye 15502
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety of using the NaviAid™ G-Eye system during Colonoscopy

Conditions

Colorectal Cancer; Polyp; Adenoma

Keywords

Colorectal Cancer; Polyp; Adenoma; Detection Rate; Colonoscopy; NaviAid™ G-Eye procedure; NaviAid™ G-Eye system; G-Eye procedure; G-Eye system

Outcome Measures

Primary Outcomes (1)

• Number of adverse events

  To evaluate the safety of using the NaviAid™ G-Eye system during Colonoscopy

  Subjects will be followed during the study period (approximatly 3 hours) and follow up will be done within 48-72 hours following the procedure

Study Arms (1)

NaviAid™ G-Eye procedure

EXPERIMENTAL

NaviAid™ G-Eye procedure

Device: NaviAid™ G-Eye procedure

Interventions

NaviAid™ G-Eye procedure DEVICE

NaviAid™ G-Eye procedure

NaviAid™ G-Eye procedure

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is undergoing colonoscopy for screening, for surveillance of previous colon polyp(s) or for diagnostic evaluation.
• The patient is 40-75 years old;
• The patient must understand and provide written informed consent for the procedure.

You may not qualify if:

• Subjects with inflammatory bowel disease;
• Subjects with a personal history of polyposis syndrome;
• Subjects with suspected colonic stricture potentially precluding complete colonoscopy;
• Subjects with active diverticulitis or toxic megacolon;
• Subjects with a history of radiation therapy to abdomen or pelvis;
• Pregnant or lactating female subjects;
• Subjects who are currently enrolled in another clinical investigation.
• Subjects with routine oral or parenteral use of anticoagulants
• Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
• Any patient condition deemed too risky for the study by the investigator

Sponsors & Collaborators

• Smart Medical Systems Ltd.: lead

Study Sites (1)

Elisha Hospital

Haifa, 34636, Israel

Location

Related Publications (1)

• Gralnek IM, Suissa A, Domanov S. Safety and efficacy of a novel balloon colonoscope: a prospective cohort study. Endoscopy. 2014 Oct;46(10):883-7. doi: 10.1055/s-0034-1377968. Epub 2014 Sep 16.

  PMID: 25225962 DERIVED

MeSH Terms

Conditions

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

Study Officials

• Ian M Gralnek, Prof.

  Elisha Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2012
• First Posted: December 17, 2012
• Study Start: November 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 30, 2013

Record last verified: 2013-07

Locations

IL (1)