PBASE System Idiopathic Rhinitis Clinical Investigation

NCT01844336 | Completed

• 1 other identifier: PR003
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to evaluate the performance of the PBASE system, in terms of the efficacy of treatment in patients with idiopathic rhinitis.

Conditions

Idiopathic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Change in total vasomotor rhinitis symptom score to visit 3

  From baseline to 28 days after treatment visit 1

Study Arms (2)

PBASE system 1.1 + CT100 (active treatment)

EXPERIMENTAL

Device: PBASE system 1.1 + CT100 (active treatment)

PBASE system 1.1 + CT100 (placebo treatment)

PLACEBO COMPARATOR

Device: PBASE system 1.1 + CT100 (placebo treatment)

Interventions

PBASE system 1.1 + CT100 (active treatment) DEVICE

PBASE system 1.1 + CT100 (active treatment)

PBASE system 1.1 + CT100 (placebo treatment) DEVICE

PBASE system 1.1 + CT100 (placebo treatment)

Eligibility Criteria

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

You may qualify if:

• Patients with persistent (\>12w) symptoms of idiopathic rhinitis dominated by nasal congestion (± secretion) for an average of at least 1 h per day for at least 5 days during a period of 14 days
• Having nasal congestion as major symptom, and a nasal congestion score of at least 2 (scale 0-3)
• Male or female 18 - 65 years
• Judged by the Investigator as suitable for participation in the study without safety concerns based on medical history and physical examination.
• Willing and able to provide written informed consent prior to participation in the clinical investigation
• Willing and able to comply with all study related procedures

You may not qualify if:

• Patients with Allergic rhinitis, demonstrated by either positive skin prick test, phadiatop or RAST
• Patients with a history of nasal surgery like: septoplasty, cosmetic surgery, conchal surgery or any other nasal surgery except closed reposition for nasal fracture
• History of frequent nose bleeds or a condition that increases the risk of excessive bleeding
• Pronounced anterior septal deviation or other significant nasal pathology at endoscopic examination
• Current malignancy of any kind
• Known allergy to polyvinylchloride or medicinal liquid paraffin
• Any disease, condition (medical or surgical) which, in the opinion of the investigator, might compromise the study results, or would place the subject at increased risk.
• Any implant with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, defibrillator, vagal neurostimulator, deep brain stimulation, spinal stimulator, bone growth stimulator, or cochlear implant or any other implant in the head-, and neck region.
• Previous treated with radiation on the face, head or neck regions
• Female patients: unwilling to use adequate contraceptive from the signing of the informed consent until end of the 8 week follow-up visit
• Received study drug in a clinical trial for an investigational drug within the previous 30 days, or 5 half-lives, whichever is longer

Sponsors & Collaborators

• Chordate Medical: lead

Study Sites (5)

Unknown Facility

Falun, Sweden

Location

Unknown Facility

Gothenburg, Sweden

Location

Unknown Facility

Lund, Sweden

Location

Unknown Facility

Stockholm, Sweden

Location

Unknown Facility

Västerås, Sweden

Location

Study Design

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

Study Record Dates

• First Submitted: April 24, 2013
• First Posted: May 1, 2013
• Primary Completion: August 1, 2014
• Last Updated: September 9, 2014

Record last verified: 2014-09

Locations

SE (5)