Study Designed to Clinically Evaluate Sinus Wash Device Prototypes
Pilot Study Designed to Clinically Evaluate Sinus Wash Device Prototypes in Patients With Sinusitis During Endoscopic Sinus Surgery (ESS) and in the Hospital Outpatient
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
The purpose of this study is to clinically evaluate sinus wash device prototypes in patients with sinusitis during Endoscopic Sinus Surgery (ESS) and in the hospital outpatient
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2017
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2016
CompletedFirst Posted
Study publicly available on registry
October 13, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedOctober 13, 2016
October 1, 2016
2.8 years
September 13, 2016
October 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse events
Presence of adverse events
Within day 1
Secondary Outcomes (10)
Mucosal damage visual inspection
Within 1 hour
Syringe visual inspection
Within 1 hour
Pain during procedure
Within 1 hour
Usability & Tolerability Questionnaire
Within 1 hour
Mucus leftovers visual inspection
Within 1 hour
- +5 more secondary outcomes
Study Arms (1)
Sinus irrigation
EXPERIMENTALSinus irrigation intervention
Interventions
Sinus lavage via the natural sinus ostium, without ostial dilation.
Eligibility Criteria
You may qualify if:
- Male or female, 18-65 years of age.
- Signs and symptoms of acute exacerbation during chronic maxillary sinusitis.
- Pain higher than 5 in VAS of 0-10.
- Able to understand and provide written informed consent.
You may not qualify if:
- Patients who have a clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation as determined by medical history based on the opinion of the investigator.
- Extensive sinonasal polyps that may interfere with the treatment procedure.
- Previous sinonasal surgery.
- Acute exacerbation of sinusitis in the frontal or sphenoid sinuses.
- Sinonasal osteoneogenesis.
- Cystic fibrosis.
- Sinonasal tumors or obstructive lesions.
- Presence of features consistent with sinus fungal disease on CT or physical examination.
- History of facial trauma that distorted the sinus anatomy.
- Ciliary dysfunction.
- History of insulin dependent diabetes.
- Not able to stop anti-coagulant (e.g., warfarin) until the International Normalized Ratio (INR) is below 1.5.
- Not able to stop anti-platelet (e.g., clopidogrel, aspirin, etc.) for at least 14 days prior to study procedure.
- Not able to stop any non-steroidal anti-inflammatory medications and homeopathic medications for at least 14 days prior to the study procedure.
- Pregnancy.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Itzhak Braverman, Professor
Hillel Yaffe Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2016
First Posted
October 13, 2016
Study Start
January 1, 2017
Primary Completion
November 1, 2019
Study Completion
January 1, 2020
Last Updated
October 13, 2016
Record last verified: 2016-10