Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06626477
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Intra-Nasal Mechanical Stimulation INMEST As a Potential Treatment Method for Sjogrens Syndrome SS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Intra-Nasal Mechanical Stimulation INMEST As a Potential Treatment Method for Sjogrens Syndrome SS - a Prospective Double-Blind Randomized Pilot Study to Evaluate the Safety and Performance of the Walther System
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
A-SS-001
Brief Summary:
The purpose of the study is to investigate the effect and safety of the Walther System delivering INMEST intranasal mechanical stimulation on people with Sjogrenamp39s syndrome A total of 30 subjects are planned to be enrolled and randomized to either use an active device or a sham device for the first 6 weeks During the last 6 weeks all subjects will receive active treatment The treatments are self-administered by the subject at home three times a week and 10 minutes per nostril
Subjects will
Use an active or sham device at home 3 times per week for six weeks
All subjects will then get an active device for use another six weeks
Visit the clinic every third week for measurements and checkups
Keep a diary of the treatments and potential problems
Subjects will
Use an active or sham device at home 3 times per week for six weeks
All subjects will then get an active device for use another six weeks
Visit the clinic every third week for measurements and checkups
Keep a diary of the treatments and potential problems
Detailed Description:
Clinical investigation purpose and background ----- In this investigation the intended purpose of the investigational device the Walther System is to deliver intranasal mechanical stimulation INMEST for symptom relief in cases of Sjogrens syndrome and the treatment is self-administered at home
Sjogrenamp39s syndrome is a chronic disorder of the immune system that usually affects the mucous membranes and moisture-secreting glands of the eyes and mouth The two most common symptoms of Sjogrens Syndrome are dry eyes and a dry mouth The prevalence has been reported to be 006 and the disease mostly affect women and people over 40 There are currently no treatment options for Sjogrenamp39s syndrome other than relieving symptoms resulting in medications that decrease eye inflammation increase saliva production andor suppress the immune system
Design of clinical investigation
-----
This is a randomized double-blinded single centre pilot study with a total of 30 study subjects from 18 years of both genders Randomization of study subjects is done in permuted blocks and the subjects are randomized to either one of two groups of equal size receiving either
A treatment with the investigational device active B treatment with comparator device shamcontrol After half the treatment time all subjects are given a new investigational device that is active thus all subjects will receive active treatment
After enrolment in the study including the informed consent procedure and the subsequent randomization process study subjects are assigned to either an investigational device treatment group A or a comparator treatment group group B After an initial demonstration of the device comparator or investigational device study subjects will be given the device to be used for self-administration at home 3 days a week 10 minutes per nasal cavity ie a total of 20 minutes per treatment session for a total treatment period of 12 weeks ie a total of 36 treatment sessions After 6 weeks all subjects irrespective of group will exchange their device for an investigational device thus all subjects will receive active treatment for the last 6 weeks
Clinic visits with measurements are scheduled at baseline followed at visits after 3 6 9 and 12 weeks when end of treatment is reached Every visit after baseline should be made within a time window of -3 days to 10 days Subjects are instructed not to perform any treatments with the device 12 hours prior visiting the clinic
During the study period both patients reported symptoms and objective measurements will be collected An analysis will also be made of compliance with the prescribed treatment and the safety of the investigational medical device will be evaluated through analysis of reported adverse events and device deficiencies
Sjogrenamp39s syndrome is a chronic disorder of the immune system that usually affects the mucous membranes and moisture-secreting glands of the eyes and mouth The two most common symptoms of Sjogrens Syndrome are dry eyes and a dry mouth The prevalence has been reported to be 006 and the disease mostly affect women and people over 40 There are currently no treatment options for Sjogrenamp39s syndrome other than relieving symptoms resulting in medications that decrease eye inflammation increase saliva production andor suppress the immune system
Design of clinical investigation
-----
This is a randomized double-blinded single centre pilot study with a total of 30 study subjects from 18 years of both genders Randomization of study subjects is done in permuted blocks and the subjects are randomized to either one of two groups of equal size receiving either
A treatment with the investigational device active B treatment with comparator device shamcontrol After half the treatment time all subjects are given a new investigational device that is active thus all subjects will receive active treatment
After enrolment in the study including the informed consent procedure and the subsequent randomization process study subjects are assigned to either an investigational device treatment group A or a comparator treatment group group B After an initial demonstration of the device comparator or investigational device study subjects will be given the device to be used for self-administration at home 3 days a week 10 minutes per nasal cavity ie a total of 20 minutes per treatment session for a total treatment period of 12 weeks ie a total of 36 treatment sessions After 6 weeks all subjects irrespective of group will exchange their device for an investigational device thus all subjects will receive active treatment for the last 6 weeks
Clinic visits with measurements are scheduled at baseline followed at visits after 3 6 9 and 12 weeks when end of treatment is reached Every visit after baseline should be made within a time window of -3 days to 10 days Subjects are instructed not to perform any treatments with the device 12 hours prior visiting the clinic
During the study period both patients reported symptoms and objective measurements will be collected An analysis will also be made of compliance with the prescribed treatment and the safety of the investigational medical device will be evaluated through analysis of reported adverse events and device deficiencies
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