Safety and efficacy of using NaviAid™ BGE device for endoscopic diagnosis and treatment
| ISRCTN | ISRCTN87379760 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87379760 |
| ClinicalTrials.gov number | NCT00398203 |
| Secondary identifying numbers | Protocol No. 1 |
- Submission date
- 08/11/2006
- Registration date
- 14/11/2006
- Last edited
- 08/03/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Ingvar Bjarnason
Scientific
Scientific
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
Study information
| Study design | Open label randomised-controlled double arm single centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Safety and efficacy of using NaviAid™ BGE device for endoscopic diagnosis and treatment |
| Study objectives | 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. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Small intestine abnormality |
| Intervention | The intervations in this study are enteroscopy and BGE procedure. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 01/01/2007 |
| Completion date | 31/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2007 |
| Date of final enrolment | 31/07/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
King's College Hospital
London
SE5 9RS
United Kingdom
SE5 9RS
United Kingdom
Sponsor information
Smart Medical Systems Ltd (Israel)
Industry
Industry
10 Hayetsira Street
Ra'anana
43663
Israel
"ROR" |
https://ror.org/01w50vm31 |
|---|
Funders
Funder type
Industry
Smart Medical Systems Ltd (Israel)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
08/03/2019: No publications found. All search options exhausted.
02/02/2017: No publications found in PubMed, verifying study status with principal investigator.
17/05/2011: The anticipated end date for this trial has been updated from 01/09/2007 to 31/07/2011.
