Evaluation of cutting balloons for treatment of salivary duct strictures

ISRCTN ISRCTN91891418
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

Dental Radiology
F23 Guys Tower
Guy's Hospital
St Thomas Street
London
SE21 9RT
United Kingdom

Email jackie.brown@kcl.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleEvaluation of cutting balloons for treatment of salivary duct strictures
Study objectivesAre 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) studiedSalivary duct stenosis
InterventionA randomised controlled trial comparing the use of conventional balloons used for the treatment of salivary stenosis versus cutting balloons.
Intervention typeProcedure/Surgery
Primary outcome measureClinical evaluation and radiological (sialogram) follow up
Secondary outcome measuresNot provided at time of registration
Overall study start date01/06/2003
Completion date01/12/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants25
Key inclusion criteriaAll patients requiring treatment for salivary obstruction due to stenosis.
Key exclusion criteria1. 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 enrolment01/06/2003
Date of final enrolment01/12/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Guy's Hospital
London
SE21 9RT
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

28/07/2017: No publications found in PubMed, verifying study status with principal investigator.