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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00945022
Recruitment Status : Unknown
Verified July 2009 by IMD Tech Ltd.
Recruitment status was:  Not yet recruiting
First Posted : July 23, 2009
Last Update Posted : June 9, 2011
Sponsor:
Information provided by:
IMD Tech Ltd

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.


Condition or disease Intervention/treatment
Oral Dryness General Surgery Device: wetting lips following surgery using anesthesia

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of Safety and Efficacy of Using Lipsus Device for Oral Wetting
Study Start Date : October 2011
Estimated Primary Completion Date : February 2012
Estimated Study Completion Date : April 2012

Arm Intervention/treatment
Experimental: Lipsus Device: wetting lips following surgery using anesthesia
The investigator will position the Lipsus device in accordance with the instructions for use



Primary Outcome Measures :
  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). [ Time Frame: 2 days ]

Secondary Outcome Measures :
  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. [ Time Frame: 2 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Hanna Levy, IMD Tech Ltd
ClinicalTrials.gov Identifier: NCT00945022     History of Changes
Other Study ID Numbers: WL - 01
First Posted: July 23, 2009    Key Record Dates
Last Update Posted: June 9, 2011
Last Verified: July 2009

Keywords provided by IMD Tech Ltd:
General Surgery