Safety and Efficacy of SDX-3101 for the Treatment of Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

NCT04158596 | Withdrawn DMC

• 1 other identifier: SDX-3101
• Study Type: interventional
• Target: N/A
• Locations: 3 countries
• Sites: 8

Brief Summary

The purpose of this clinical trial is to assess the safety and efficacy of SDX-3101 for treatment of adult patients with chronic rhinosinusitis without nasal polyps (CRSsNP) by investigating a vibration pattern of SDX-3101 compared to a control

Conditions

Chronic Rhinosinusitis Without Nasal Polyps

Outcome Measures

Primary Outcomes (1)

• SNOT-20 GAV

  The primary endpoint is the change in subjective symptoms as quantified by the German validated disease-specific 20-item Sino-nasal Outcome Test (SNOT-20 GAV) after 12 weeks. Superiority is defined as more than minimal clinically important difference (MCID) of 8.9 points to active control of SNOT-20 score at 12 weeks.

  12 weeks

Secondary Outcomes (8)

• Lund-Kennedy Score

  day 0, day 14, week 6, 12 and at 6, 9 and 12 months

• Overall disease control

  day 14, week 6, 12 and at 6, 9 and 12 months

• Need for surgical intervention

  day 14, week 6, 12 and at 6, 9 and 12 months

• Ability to perform normal activities

  day 0, day 14, week 6, 12 and at 6, 9 and 12 months,

• Acceptability of treatment

  day 14, week 6, 12 and at 6, 9 and 12 months

Other Outcomes (3)

• Saccharine test

  day 0, week 6, 12 weeks and at 12 months

• Reduction in inflammatory markers

  day 0, day 14, week 6, 12

• Exhaled nasal Nitric Oxide (nNO) levels

  day 0, day 14, week 6, 12 and 12 months

Study Arms (2)

Treatment

EXPERIMENTAL

The applied therapeutic vibrations generated by an acoustic coil have a defined sweeping frequency range.

Device: Vibration Therapy

Control

ACTIVE COMPARATOR

A control device with a different vibration pattern will be used as comparator intervention

Device: Vibration Therapy

Interventions

Vibration Therapy DEVICE

SDX-3101 is used for drug-free treatment of CRSsNP in adults.

Control; Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male or female subjects between 18 and 70 years old
• Diagnosed history of chronic rhinosinusitis without nasal polyps (CRSsNP) defined as per EPOS Guidelines.
• Moderate to severe baseline SNOT-20 GAV score (\> 20)
• Willingness to stop nasal saline irrigation and drug therapy for CRSsNP (restart later on possible)

You may not qualify if:

• Subjects with local pathology that would compromise the ability to either administer the device or assess the benefits/risks (e.g. mucocele, antrochoanal polyp, facial trauma, radiation injury, or birth defect)
• Systemic corticosteroids if not stop for 14 days before study enrolment
• Subjects suffering from insufficiently controlled asthma
• Subjects suffering from insufficiently controlled allergic rhinitis (AR)
• Subjects with prior sinus operations within the last 4 months
• Subjects with known primary ciliary dyskinesia/cystic fibrosis
• Subjects with serious underlying medical condition
• Ongoing oncological treatments
• Known hypersensitivity to materials in direct contact with the skin
• Metal or metal-like implant (incl. ceramic) located in the head or neck area. Unremovable hearing aids
• Patients with implanted cardiac pace-maker
• Women who are pregnant or breast feeding
• Known or suspected non-compliance, drug or alcohol abuse,
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant

Sponsors & Collaborators

• SynDermix AG: lead
• ISS AG: collaborator

Study Sites (8)

Kardinal Schwarzenberg Klinikum GmbH

Schwarzach im Pongau, 5620, Austria

Location

Praxis Dr.med. Decot

Dreieich, 63303, Germany

Location

ENT Research Institut für Klinische Studien

Essen, 45355, Germany

Location

HNO Praxis am Neckar

Heidelberg, 69120, Germany

Location

HNO - Arzt Allergologe Studienzentrum

Viernheim, 68519, Germany

Location

Helios Universitätsklinikum Wuppertal

Wuppertal, 42283, Germany

Location

Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten, Kopf- und Halschirurgie, Inselspital,

Bern, 3010, Switzerland

Location

Department of ENT, Head and Neck Surgery Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

Study Officials

• Carlos R Camozzi, MD

  SynDermix AG

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 12, 2019
• Study Start: June 1, 2020
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2021
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5); CH (2); AU (1)