Condition category
Digestive System
Date applied
08/11/2006
Date assigned
14/11/2006
Last edited
01/05/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ingvar Bjarnason

ORCID ID

Contact details

King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00398203

Protocol/serial number

Protocol No. 1

Study information

Scientific title

Acronym

Study hypothesis

Balloon Guided Endoscopy (BGE) is a procedure intended for the examination of the small intestine, which utilises the NaviAid™ BGE device in conjunction with a standard endoscope.

Hypothesis:
To assess the efficacy of the Naviaid™ Balloon Guided Endoscope (BGE) device, while used in conjunction with a standard endoscope for the diagnosis and treatment of the small intestine.

As of 17/05/2011 the anticipated end date for this trial has been updated from 01/09/2007 to 31/07/2011.

Ethics approval

Approval is expected by the end of December 2006.

Study design

Open label, randomised-controlled, double arm, single centre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Small intestine abnormality

Intervention

The intervations in this study are enteroscopy and BGE procedure.

Intervention type

Device

Phase

Not Specified

Drug names

Primary outcome measures

Depth of small intestine visualisation

Secondary outcome measures

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

Overall trial start date

01/01/2007

Overall trial end date

31/07/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male/female aged between 18 and 80 years (inclusive)
2. Subject is scheduled for endoscopic procedure after the case was reviewed by one of the investigators
3. Symptomatic subject defined as having at least one of the following signs or symptoms:
3.1. Abdominal pain
3.2. Cramps
3.3. Bloating
3.4. Diarrhoea
3.5. Nausea
3.6. Vomiting
3.7. Unexplained anaemia
3.8. Gastro-Intestinal (GI) bleeding from an unknown source
3.9. Small bowel abnormality on any imaging study
4. Subject able to comprehend and give informed consent for participation in this study
5. Signed informed consent form

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Pregnancy
2. Acute bowel obstruction
3. Concomitant coumadin or warfarin use
4. Severe diverticulitis
5. Recent (within the last three months) coronary ischemia or Coronary Vascular Accident (CVA - stroke)
6. Any chronic unstable disease
7. Bleeding disorders
8. Needing emergency surgery
9. Any patient condition deemed too risky for BGE by the investigator
10. Known cognitive or psychiatric disorder
11. Physician objection
12. Concurrent participation in any other clinical trial

Recruitment start date

01/01/2007

Recruitment end date

31/07/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College Hospital
London
SE5 9RS
United Kingdom

Sponsor information

Organisation

Smart Medical Systems Ltd (Israel)

Sponsor details

10 Hayetsira Street
Ra'anana
43663
Israel

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Smart Medical Systems Ltd (Israel)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes