Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00509808
Status:
COMPLETED
Last Update Posted:
2010-04-06
First Post:
2007-07-31
Brief Title:
Evaluation of an Electro-stimulator for the Treatment of Xerostomia
Sponsor:
Saliwell Ltd
Organization:
Saliwell Ltd
Study Overview
Official Title:
Safety and Performance Evaluation of an Electro-stimulator Mounted on an Intra-oral Removable Appliance Saliwell GenNarino for the Treatment of Xerostomia
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GenNarino
Brief Summary:
This is a multinational trial aimed at testing the safety and performance of a electrostimulating device GenNarino to treat dry mouth over one year The design is as follows
Multi-center double blind sham placebo controlled about 10 xerostomia patients per center
Patients receive a GenNarino and its remote control that is programmed for one month sham and one month active mode the order of which is randomly assigned and thereafter 9 months at the active mode divided in period of 3 months the order of each is randomly assigned at wearing GenNarino for 1 5 or 10 minutes at a time
Study hypothesis Gennarino will lead to significant symptomatic improvement
- At the clinic monthly examinations at the first 2 months and then every 3 months including whole saliva collection and questionnaire at the first visit impression taking for GenNarino preparation
Multi-center double blind sham placebo controlled about 10 xerostomia patients per center
Patients receive a GenNarino and its remote control that is programmed for one month sham and one month active mode the order of which is randomly assigned and thereafter 9 months at the active mode divided in period of 3 months the order of each is randomly assigned at wearing GenNarino for 1 5 or 10 minutes at a time
Study hypothesis Gennarino will lead to significant symptomatic improvement
- At the clinic monthly examinations at the first 2 months and then every 3 months including whole saliva collection and questionnaire at the first visit impression taking for GenNarino preparation
Detailed Description:
The clinical trial titled Safety and performance evaluation of an electro-stimulator mounted on an intra-oral removable appliance GenNarino for the treatment of xerostomia is a prospective randomized double-blind sham-controlled multi-center trial followed by an open-label study Study subjects are patients with xerostomia The purpose of the trial is to test the safety and efficacy of electrostimulation using the GenNarino device
The primary endpoint is significant symptomatic improvement and the secondary ones increased salivary output and event free use no adverse side-effects The clinical follow-up consists of periodic clinical examinations
In this clinical trial the use of the device is compared between active vs sham mode for one month each in a double-blind design Stage I Thereafter at Stage II the xerostomia relieving effect of the active device is assessed in an open label design for additional 6 months Clinic- and home-based questionnaires and whole saliva collections are performed
The primary endpoint is significant symptomatic improvement and the secondary ones increased salivary output and event free use no adverse side-effects The clinical follow-up consists of periodic clinical examinations
In this clinical trial the use of the device is compared between active vs sham mode for one month each in a double-blind design Stage I Thereafter at Stage II the xerostomia relieving effect of the active device is assessed in an open label design for additional 6 months Clinic- and home-based questionnaires and whole saliva collections are performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None