Safety and Efficacy of Using NaviAid™ BGE Device (Balloon Guided Endoscopy) For Endoscopic Diagnosis and Treatment

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Smart Medical Systems Ltd.

ClinicalTrials.gov Identifier:

NCT00398203

First received: November 8, 2006

Last updated: June 11, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 8, 2006

Last Updated Date

June 11, 2012

Start Date ^ICMJE

February 2008

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Efficacy will be assessed by comparing NaviAid™ BGE Device performances to a reference Enteroscopy procedure in terms of depth of small intestine advancement and visualization. [ Time Frame: Within 6 months of completion of the trial ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Depth of small intestine visualization:
Advancement depth (cm) will be measured from pylorus or cecum entry point (for oral or anal approach, respectively).

Change History

Complete list of historical versions of study NCT00398203 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety of the NaviAid™ BGE Device will be assessed by reporting adverse events, and by comparing to a reference Enteroscopy procedure. [ Time Frame: Within 6 months of completion of the trial ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

The safety endpoint(secondary) is incidence of treatment related major complications.
Major complications are:Blood transfusion,Adverse event requiring treatment associated with elongation of hospital stay for more than 24 hours beyond the standard at the specific site,
Complications associated with permanent sequelae,Death

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of Using NaviAid™ BGE Device (Balloon Guided Endoscopy) For Endoscopic Diagnosis and Treatment

Official Title ^ICMJE

Safety and Efficacy of Using NaviAid™ BGE Device (Balloon Guided Endoscopy) For Endoscopic Diagnosis and Treatment

Brief Summary

To assess the efficacy of the NaviAid™ BGE Device, while used in conjunction with a standard endoscope for the diagnosis and treatment of the small intestine.

Detailed Description

Smart Medical Systems has developed the NaviAid™ Balloon Guided Endoscopy (BGE) Device, an innovative medical device for the GI tract diagnosis and treatment. The Balloon Guided Endoscopy (BGE) is a procedure intended for the examination of the small intestine, which utilizes the NaviAid™ BGE Device in conjunction with a standard endoscope.

The objectives of this prospective controlled study are to evaluate the safety and efficacy of using the NaviAid™ BGE device in the examination of the small intestine in conjunction with a standard endoscope.

Efficacy will be assessed by comparing NaviAid™ BGE Device performances to a reference Enteroscopy procedure.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Intestinal Diseases

Intervention ^ICMJE

Device: NaviAid™ BGE Device

NaviAid™ Balloon Guided Endoscopy Device

Other Name: NaviAid™ Balloon Guided Endoscopy Device

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2011

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male/Female aged between 18-80 years (inclusive).
Subject is scheduled for endoscopic procedure after the case was reviewed by one of the investigators.
Symptomatic subject defined as having at least one of the following signs or symptoms:
- Abdominal pain
- Cramps
- Bloating
- Diarrhea
- Nausea
- Vomiting
- Unexplained Anemia
- GI bleeding from an unknown source
- Small bowel abnormality on any imaging study
Subject able to comprehend and give informed consent for participation in this study
Signed Informed Consent Form

Exclusion Criteria:

Pregnancy
Acute bowel obstruction
Concomitant Coumadin or warfarin use
Severe diverticulitis
Recent (within the last 3 months) coronary ischemia or CVA (stroke)
Any chronic unstable disease
Bleeding disorders
Needing emergency surgery
Any patient condition deemed too risky for SBE by the investigator
Known cognitive or psychiatric disorder
Physician objection
Concurrent participation in any other clinical trial

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00398203

Other Study ID Numbers ^ICMJE

CLI-10111

Has Data Monitoring Committee

Responsible Party

Smart Medical Systems Ltd.

Study Sponsor ^ICMJE

Smart Medical Systems Ltd.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ingvar Bjarnason, Prof.

Kings College Hospital

Information Provided By

Smart Medical Systems Ltd.

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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