Oral DrynessNCT00945022
Evaluation of Safety and Efficacy of Using Lipsus Device for Oral Wetting
A study testing wetting lips following surgery using anesthesia in people with Oral Dryness and General Surgery, run by IMD Tech Ltd at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Dryness, General Surgery
- What is being tested?
- wetting lips following surgery using anesthesia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2011to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Subject objects to the study protocol.
- Concurrent participation in any other clinical study
- Physician objection
Trial locations and contacts
1 site in 1 country.
Israel1 site
Shaari Zedek Medical Center
Jerusalem
Hanna Levy, Dr., (972)-4-638-8837, hanna@qsitemed.com
Alexander Yuskavitch, Dr.
About this study
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.
- Conditions
- Oral Dryness, General Surgery
- Being tested
- wetting lips following surgery using anesthesia
- Keywords
- General Surgery
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wetting lips following surgery using anesthesiaDevice
The investigator will position the Lipsus device in accordance with the instructions for use
| Study group | Role | What they receive |
|---|---|---|
| Lipsus | Experimental | Not described Receives: Device: wetting lips following surgery using anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startOct 2011
- Primary completionFeb 2012 (estimated)
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral DrynessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IMD Tech Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alexander Yuskavitch, Dr., Principal investigator, Shaari Zedek Medical Center, Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945022
- Sponsor's protocol ID
- WL - 01
- Status last verified
- Jul 2009
- First submitted
- 13 Jul 2009
- Last updated
- 9 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of Using Lipsus Device for Oral Wetting
- ClinicalTrials.gov ID
- NCT00945022
- Acronym / sponsor ID
- WL - 01
- Conditions
- Oral Dryness, General Surgery
- Keywords
- General Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IMD Tech LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 23 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lipsus | Experimental | Device: wetting lips following surgery using anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wetting lips following surgery using anesthesiaThe investigator will position the Lipsus device in accordance with the instructions for use | Device | Lipsus |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2011.
Related trials for Oral Dryness
Not yet recruiting
Effects of a 50+ Toothpaste on Halitosis and Oral Comfort in Healthy Adults
Oral Malodor (Halitosis), Oral Dryness
Recruiting
The Effects of Using Augmented Reality (AR) System to Train Foreign Care Workers.
Oral Dryness and Saliva Altered, Oral Manifestations
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Yuskavitch, Dr. principal investigator
Shaari Zedek Medical Center, Jerusalem
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wetting lips following surgery using anesthesia in people with Oral Dryness and General Surgery, run by IMD Tech Ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanna Levy, Dr ((972)-4-638-8837, hanna@qsitemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2011; AzTrials last refreshed its copy on 7 Nov 2026.