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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00945022

Enrollment

100

Registered

2009-07-23

Start date

2011-10-31

Completion date

2012-04-30

Last updated

2011-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Surgery, Oral Dryness

Keywords

General Surgery

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.

Interventions

DEVICEwetting lips following surgery using anesthesia

The investigator will position the Lipsus device in accordance with the instructions for use

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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).	2 days

Secondary

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.	2 days

Countries

Israel

Contacts

Primary ContactHanna Levy, Dr

hanna@qsitemed.com(972)-4-638-8837

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026