Back to resultsEvaluation of Safety and Efficacy of Using Lipsus Device for Oral Wetting
Primary Purpose
Oral Dryness, General Surgery
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
wetting lips following surgery using anesthesia
Sponsored by
About this trial
This is an interventional supportive care trial for Oral Dryness focused on measuring General Surgery
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Shaari Zedek Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lipsus
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00945022
Brief Title
Evaluation of Safety and Efficacy of Using Lipsus Device for Oral Wetting
Official Title
Evaluation of Safety and Efficacy of Using Lipsus Device for Oral Wetting
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
February 2012 (Anticipated)
Study Completion Date
April 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
IMD Tech Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Dryness, General Surgery
Keywords
General Surgery
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lipsus
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
wetting lips following surgery using anesthesia
Intervention Description
The investigator will position the Lipsus device in accordance with the instructions for use
Primary Outcome Measure Information:
Title
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).
Time Frame
2 days
Secondary Outcome Measure Information:
Title
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.
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanna Levy, Dr
Phone
(972)-4-638-8837
Email
hanna@qsitemed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Yuskavitch, Dr.
Organizational Affiliation
Shaari Zedek Medical Center, Jerusalem
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaari Zedek Medical Center
City
Jerusalem
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanna Levy, Dr.
Phone
(972)-4-638-8837
Email
hanna@qsitemed.com
First Name & Middle Initial & Last Name & Degree
Alexander Yuskavitch, Dr.
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Safety and Efficacy of Using Lipsus Device for Oral Wetting
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