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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by IMD Tech Ltd.
Recruitment status was:  Not yet recruiting
Information provided by:
IMD Tech Ltd Identifier:
First received: July 13, 2009
Last updated: June 8, 2011
Last verified: July 2009

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: 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

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 ]

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 ]

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00945022

Contact: Hanna Levy, Dr (972)-4-638-8837

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

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

Keywords provided by IMD Tech Ltd:
General Surgery processed this record on May 24, 2017