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
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||Phase|
|Oral Dryness General Surgery||Device: wetting lips following surgery using anesthesia||Not Applicable|
|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|
Device: wetting lips following surgery using anesthesia
The investigator will position the Lipsus device in accordance with the instructions for use
- 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 ]
- 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 ]
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
|Contact: Hanna Levy, Dr||(972)-email@example.com|
|Shaari Zedek Medical Center||Not yet recruiting|
|Contact: Hanna Levy, Dr. (972)-4-638-8837 firstname.lastname@example.org|
|Principal Investigator: Alexander Yuskavitch, Dr.|
|Principal Investigator:||Alexander Yuskavitch, Dr.||Shaari Zedek Medical Center, Jerusalem|