NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: Abilion Medical Systems AB
Conditions: Sjogren Syndrome
Interventions: Intra nasal mechanical stimulation treatment (INMEST), Sham (No Treatment)
Countries: Sweden
The purpose of the study is to investigate the effect and safety of the Walther System delivering INMEST (intranasal mechanical stimulation) on people with Sjogren\'s 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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: 1. Age ≥ 18 years at inclusion date 2. Schirmer's test ≤ 5 mm for both eyes 3. NIBUT ≤ 10 s for both eyes 4. Previous positive result of blood test for sample anti-Ro (SS-A) or anti-La (SS-B), as indicated by medical record or lab result shown by the subject. 5. The study subject reports having understood and have signed the Informed Consent Form (ICF) and is willing to comply with all investigation visits and assessments. 6. Women of childbearing potential must agree to use a reliable, medically approved form of contraception during the study participation until end of study. 7. Anticipated compliance with prescribed treatment and follow-up. Exclusion Criteria: 1. Recently (12 months prior enrolment) undergone nasal, sinus, or ocular surgery. 2. Presence of an ocular or respiratory condition that could affect the study parameters such as active ocular infection/inflammation, glaucoma, diabetic retinopathy, or upper respiratory tract infection per the Investigator's judgement. 3. The study subject has a cognitive incapacity or language barrier precluding adequate understanding or cooperation. 4. Any severe diseases interfering with the performance, evaluation, and outcome of the clinical evaluation. 5. The study subject is considered by the Investigator to be unsuitable to participate in the investigation for any other reason. 6. Previous (within 30 days prior to enrolment) and concurrent treatment with another investigational drug/s or device/s. 7. Subject is pregnant or lactating or planning to get pregnant during the duration of the study.
- Solna, Stockholm County, Sweden