Evaluation of cutting balloons for treatment of salivary duct strictures
ISRCTN | ISRCTN91891418 |
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DOI | https://doi.org/10.1186/ISRCTN91891418 |
Secondary identifying numbers | N0013145948 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 28/07/2017
- 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
Mrs Jackie Brown
Scientific
Scientific
Dental Radiology
F23 Guys Tower
Guy's Hospital
St Thomas Street
London
SE21 9RT
United Kingdom
jackie.brown@kcl.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | Evaluation of cutting balloons for treatment of salivary duct strictures |
Study objectives | Are cutting balloons more effective than conventional angioplasty balloons for treating salivary duct strictures? |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Salivary duct stenosis |
Intervention | A randomised controlled trial comparing the use of conventional balloons used for the treatment of salivary stenosis versus cutting balloons. |
Intervention type | Procedure/Surgery |
Primary outcome measure | Clinical evaluation and radiological (sialogram) follow up |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/06/2003 |
Completion date | 01/12/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 25 |
Key inclusion criteria | All patients requiring treatment for salivary obstruction due to stenosis. |
Key exclusion criteria | 1. Any patient suffering from an acute or chronic systemic illness that renders them unsuitable for elective outpatient dental treatment under local anaesthesia 2. Pregnant women 3. Patients exhibiting signs or symptoms of acute infection of the salivary gland under examination 4. Patients with an allergy to iodine (as in radiographic contrast agents) or local anaesthetic agents |
Date of first enrolment | 01/06/2003 |
Date of final enrolment | 01/12/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Guy's Hospital
London
SE21 9RT
United Kingdom
SE21 9RT
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Guy's and St. Thomas' NHS Foundation Trust (UK)
No information available
Own account
No information available
NHS R&D Support Funding (UK)
No information available
Results and Publications
Intention to publish date | |
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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
28/07/2017: No publications found in PubMed, verifying study status with principal investigator.