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

General Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00945022
• Other study ID #: WL - 01
• Status: Not yet recruiting
• Phase: N/A
• First received: July 13, 2009
• Last updated: June 8, 2011
• Start date: October 2011
• Est. completion date: April 2012

Study information

• Verified date: July 2009
• Source: IMD Tech Ltd
• Contact: Hanna Levy, Dr
• Phone: (972)-4-638-8837
• Email: hanna[@]qsitemed.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• General Surgery
• Oral Dryness

Intervention

Device:
• wetting lips following surgery using anesthesia
The investigator will position the Lipsus device in accordance with the instructions for use

Locations

Country	Name	City	State
Israel	Shaari Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
IMD Tech Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		2 days	Yes
Secondary	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.		2 days	No