NCT06626477Completed
Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Treatment Method for Sjogren's Syndrome (SS)
Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Treatment Method for Sjogren's Syndrome (SS) - a Prospective, Double-Blind, Randomized Pilot Study To Evaluate the Safety and Performance of the Walther System
Source: ClinicalTrials.gov · Last updated 3 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 26 (actual)
- First submitted
- 30 Sept 2024
- Start date
- 5 Nov 2024
- Primary completion date
- 19 Jul 2025
- Lead sponsor
- Abilion Medical Systems AB
- Diseases
- Sjögren's disease
- NCT number
- NCT06626477
What you commit to
- Study type: Interventional
- Participants enrolled: 26
- From 5 Nov 2024 to the primary completion date, 19 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recently (12 months prior enrolment) undergone nasal, sinus, or ocular surgery.
- Previous (within 30 days prior to enrolment) and concurrent treatment with another investigational drug/s or device/s.
Other illness
- 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.
- Any severe diseases interfering with the performance, evaluation, and outcome of the clinical evaluation.
Other
- The study subject has a cognitive incapacity or language barrier precluding adequate understanding or cooperation.
- The study subject is considered by the Investigator to be unsuitable to participate in the investigation for any other reason.
- Subject is pregnant or lactating or planning to get pregnant during the duration of the study.
Who the study is looking for
- Age ≥ 18 years at inclusion date
- Schirmer's test ≤ 5 mm for both eyes
- NIBUT ≤ 10 s for both eyes
- 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.
- 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.
- Women of childbearing potential must agree to use a reliable, medically approved form of contraception during the study participation until end of study.
- Anticipated compliance with prescribed treatment and follow-up.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Källmarkskliniken AB Coordinator of this site? Confirm its status | Solna | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.