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

June 8, 2011 updated by: IMD Tech Ltd

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Jerusalem, Israel
        • Shaari Zedek Medical Center
        • Principal Investigator:
          • Alexander Yuskavitch, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IMD Tech Ltd

Investigators

  • Principal Investigator: Alexander Yuskavitch, Dr., Shaari Zedek Medical Center, Jerusalem

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

February 1, 2012

Study Completion (Anticipated)

April 1, 2012

Study Registration Dates

First Submitted

July 13, 2009

First Submitted That Met QC Criteria

July 22, 2009

First Posted (Estimate)

July 23, 2009

Study Record Updates

Last Update Posted (Estimate)

June 9, 2011

Last Update Submitted That Met QC Criteria

June 8, 2011

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WL - 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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