Status:
UNKNOWN
Evaluation of Safety and Efficacy of Using Lipsus Device for Oral Wetting
Lead Sponsor:
IMD Tech Ltd
Conditions:
Oral Dryness
General Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Following waking up from surgery performed under general anesthesia, patients are suffering from discomforting oral dryness, and moreover, they are not allowed drinking for 24 hours. The current manag...
Eligibility Criteria
Inclusion
- Subject is scheduled for surgery under general anesthesia.
- Male/female age 18 and up.
- Subject able to comprehend and give informed consent for participation in this study
- Subject must sign the Informed Consent Form.
Exclusion
- Subjects who have any form of suspicious lesion in treatment target area.
- Pregnant or lactating Subjects
- Subjects with any infection / abscess / bleeding / blister / crack / edema / fissure / ulcer / pain in treatment target area.
- Eczema or dermatitis in treatment target area
- Subjects on drugs or psychologically determined unsuitable for the study.
- Subject is suffering extreme general weakness.
- Subject objects to the study protocol.
- Concurrent participation in any other clinical study
- Physician objection
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2012
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00945022
Start Date
October 1 2011
End Date
April 1 2012
Last Update
June 9 2011
Active Locations (1)
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1
Shaari Zedek Medical Center
Jerusalem, Israel