Evaluation of Safety and Efficacy of Using Lipsus Device for Oral Wetting
1 other identifier
interventional
100
1 country
1
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 management involves the wetting of patient's lips using wet bandage. This action is dependent on the presence of a family member or a nurse, which is not always possible. Many patients describe the oral dryness as a suffering, added to the suffering anyway entailed by surgery. The investigated Lipsus device is intended for oral wetting, relieving patient's suffering and minimizing the dependence on continuous presence next to patient's bed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2009
CompletedFirst Posted
Study publicly available on registry
July 23, 2009
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedJune 9, 2011
July 1, 2009
4 months
July 13, 2009
June 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The safety of using the Lipsus device for oral wetting will be established by physician's assessment/observation of adverse events (signs of pain, allergies, infection or any adverse effect).
2 days
Secondary Outcomes (1)
The efficacy of using the Lipsus device for oral wetting will be established by Level of oral dryness improvement measured by VAS oral dryness questionnaire.
2 days
Study Arms (1)
Lipsus
EXPERIMENTALInterventions
The investigator will position the Lipsus device in accordance with the instructions for use
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- IMD Tech Ltdlead
Study Sites (1)
Shaari Zedek Medical Center
Jerusalem, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander Yuskavitch, Dr.
Shaari Zedek Medical Center, Jerusalem
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 13, 2009
First Posted
July 23, 2009
Study Start
October 1, 2011
Primary Completion
February 1, 2012
Study Completion
April 1, 2012
Last Updated
June 9, 2011
Record last verified: 2009-07