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Evaluation of Safety and Efficacy of Using Lipsus Device for Oral Wetting

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by IMD Tech Ltd.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
IMD Tech Ltd
ClinicalTrials.gov Identifier:
NCT00945022
First received: July 13, 2009
Last updated: June 8, 2011
Last verified: July 2009
History of Changes
  Purpose

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.


Condition Intervention
Oral Dryness
General Surgery
 Device: wetting lips following surgery using anesthesia

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Evaluation of Safety and Efficacy of Using Lipsus Device for Oral Wetting

Resource links provided by NLM:

MedlinePlus related topics: Dry Mouth
U.S. FDA Resources

Further study details as provided by IMD Tech Ltd:

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). [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2011
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lipsus Device: wetting lips following surgery using anesthesia
The investigator will position the Lipsus device in accordance with the instructions for use

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00945022

Contacts
Contact: Hanna Levy, Dr (972)-4-638-8837 hanna@qsitemed.com

Locations
Israel
Shaari Zedek Medical Center Not yet recruiting
Jerusalem, Israel
Contact: Hanna Levy, Dr.     (972)-4-638-8837     hanna@qsitemed.com    
Principal Investigator: Alexander Yuskavitch, Dr.            
Sponsors and Collaborators
IMD Tech Ltd
Investigators
Principal Investigator: Alexander Yuskavitch, Dr. Shaari Zedek Medical Center, Jerusalem
  More Information

No publications provided

Responsible Party: Dr. Hanna Levy, IMD Tech Ltd
ClinicalTrials.gov Identifier: NCT00945022     History of Changes
Other Study ID Numbers: WL - 01
Study First Received: July 13, 2009
Last Updated: June 8, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by IMD Tech Ltd:
General Surgery

Additional relevant MeSH terms:
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013