Acute Bacterial SinusitisSinus-EndoNCT03766568
Single Use Device Endoscopy for the Diagnosis of Acute Bacterial Rhinosinusitis in Primary Care
A study testing JGG endoscope(R) in people with Acute Bacterial Sinusitis, run by Dominik Glinz at 6 sites in Switzerland.
Trial summary
This is a pilot study to assess the first time use of the JGG endoscope® in humans and in primary care. The JGG endoscope® is attached to a Heine® otoscope and allows to inspect and to collect samples from the middle meatus of the sinus. The JGG endoscope® is sterile packaged, for one way use and disposable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Bacterial Sinusitis
- What is being tested?
- JGG endoscope(R)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesSwitzerland
- Study dates
- 17 Dec 2018to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults patients aged ≥18 years, with acute rhinosinusitis
- Duration: worsening of symptoms after 5 days after onset of symptoms or if symptoms persist for more than 10 days, but no longer than 28 days. In addition, Criteria 1 and 2 must be fulfilled.
- Criteria 1 for acute rhinosinusitis:
- [Nasal blockage/obstruction/congestion OR Nasal Discharge (anterior/ posterior nasal drip)] AND [Facial pain/ pressure OR Reduction or loss of smell]
- Criteria 2 for acute bacterial rhinosinusitis
- Indicated by the presence of at least one of the following symptoms:
Show all 11Show fewer
- discoloured discharge (unilateral predominance)
- severe local pain (unilateral predominance)
- fever, that is >38°C
- elevated inflammatory markers (CRP)
- 'double sickening' whereby the patient's condition deteriorates.
Who cannot join
- Not being able to provide written informed consent in German (due to any mental or intellectual problem or other reasons)
- Not being available for follow-up
- Previous participation in Sinus-Endo study
- Use of antibiotic the last 4 weeks
- Known pathology or malformation of the sinuses or nasal cavity (like polyposis)
- Known pregnancy
- Allergic reactions to local anaesthetics
- Anticoagulation therapy
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Switzerland6 sites, 6 recruiting
- Recruiting
HNO Klinik, University Hospital Basel
Basel, Canton of Basel-City, 4031
Katharina Leitmeyer, MD, +41 61 328 71 08
- Recruiting
mediX toujours Basel
Basel, Canton of Basel-City, 4051
Caroline Trutmann, MD, +41 61 500 11 00
- Not yet recruiting
Praxis Hammer
Basel, Canton of Basel-City, 4057
Claus Diermayr, MD, +41 61 692 88 11
- Recruiting
Praxis Vogt
Liestal, Basel-Landschaft, 4410
Jürg Vogt, MD, +619310080
- Recruiting
Hausarztpraxis Muttenz AG
Muttenz, Basel-Landschaft, 4132
Bernhard Schaller, MD, +41614612828
- Recruiting
mediX toujours Pratteln
Pratteln, Basel-Landschaft, 4133
Andreas Marti, MD, +41 61 825 90 90
About this study
Official title: Single Use Device Endoscopy for the Diagnosis of Acute Bacterial Rhinosinusitis in Primary Care: A Pilot and Feasibility Study
This is a pilot study to assess the first time use of the JGG endoscope® in humans and in primary care. The JGG endoscope® is attached to a Heine® otoscope and allows to inspect and to collect samples from the middle meatus of the sinus. The JGG endoscope® is sterile packaged, for one way use and disposable.
Read the detailed description
Acute rhinosinusitis is one of the most common reasons for consultations and antibiotic prescriptions in primary care although the condition is primarily of viral origin. The main reason for antibiotic overuse in acute rhinosinusitis is the lack of diagnostic tests of sufficient accuracy to confirm or rule out the diagnosis of acute bacterial rhinosinusitis (ABRS).
The gold standard for the diagnosis of ABRS is a bacterial culture from sinus maxillary puncture. This procedure is painful, prone to complications and only done in selected patients by oto-rhino-laryngology (ORL) specialists or for research purposes. Therefore, endoscopy of the middle meatus and collection of diagnostic material from the ostium draining the sinus is the diagnostic method of choice for ABRS and routinely used by ORL specialists in house and elsewhere. In patients with clinical symptoms of sufficient severity and duration (typically 5-10 days) for ABRS, endoscopy has a sensitivity of 85.7% (95% confidence interval, 56.2-97.5), specificity of 90.6% (73.8-97.5), positive predictive value of 80% (51.4-94.7), negative predictive value of 93.5% (77.2-98.9) for culture proven ABRS when compared with cultures gained from sinus puncture. Because of high upfront costs and logistical reason (disinfection) endoscopy is not used in general practice or internal medicine.
Dr. Jens G. Hansen has developed the disposable JGG endoscope® (JGG stands for the surnames of the inventor and his wife) which can be attached to the new generation of Heine® otoscopes with a LED light source that allows the inspection of the ostium in the middle meatus and collection of material for bacterial culture for the diagnosis of ABRS in primary care. After local anaesthesiology of the cavum nasi a sample material for cultures can be gained (earliest 10 min after local anaesthesia). The diagnostic procedure poses patients at minimal risk for complications and is of very little and short-termed discomfort.
In a pilot study the investigators would like to test the JGG endoscope® in 60 patients with suspected acute bacterial rhinosinusitis in the ORL unit of the University Hospital Basel and selected general practices that collaborate with the Centre for Primary Health Care of the University of Basel.
Objectives:
- To assess the feasibility of visualization and sample collection from the middle meatus with the JGG endoscope® in patients with clinically diagnosed acute bacterial rhinosinusitis in Swiss primary care setting
- to investigate whether the JGG endoscope® supports the decision of antibiotic prescribing
- to assess patients' and physicians' acceptability of the examination with the JGG endoscope®
- to investigate the prevalence of culture proven acute bacterial rhinosinusitis from samples of the middle meatus by the JGG endoscope® in patients with clinically diagnosed acute rhinosinusitis
- to investigate the number of patients with acute rhinosinusitis diagnosed by the JGG endoscope® with any and/or deferred antibiotic prescriptions
- to investigate the days with restrictions and symptoms in patients with acute rhinosinusitis with positive and negative bacterial cultures diagnosed by the JGG endoscope®
- to investigate any serious adverse event related to the JGG endoscope®.
Design Prospective observational cohort study (single arm study)
- Conditions
- Acute Bacterial Sinusitis
- Being tested
- JGG endoscope(R)
- Keywords
- Rhinosinusitis, upper respiratory tract infection, antibiotic, endoscopy, Otolaryngology, primary care
- Medical subject headings
- Rhinosinusitis, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JGG endoscope(R)Device
The JGG endoscope(R) is attached to the new generation of Heine® otoscopes with a LED light source that allows the inspection of the ostium in the middle meatus and collection of material for bacterial culture for the diagnosis of ABRS in primary care. After local anaesthesiology of the cavum nasi a sample material for cultures can be gained (earliest 10 min after local anaesthesia). The diagnostic procedure poses patients at minimal risk for complications and is of very little and short-termed discomfort.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic with JGG endoscope | Experimental | Not described Receives: Device: JGG endoscope(R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of successful JGG endoscope® application
The number of patients with successful visualization and sample collection from the middle meatus with the JGG endoscope®
Measured: Baseline Day 0
Prevalence of complications
The number of patients with complications related to the examination with the JGG endoscope®.
Measured: 2 weeks follow-up
Secondary outcomes (7)
Influence of JGG endoscope® to support the decision of antibiotic prescribing
After each examination with the JGG endoscope, each physician will report on a Likert scale with five categories how the physician would judge usefulness of the device for decision to prescribe antibiotics.(The examination with the JGG endoscope(R) supported my decision whether to prescribe antibiotics or not; possible answers 1: don't agree, 2: partially don't agree, 3: neutral, 4: partially agree, 5: agree). The findings will be presented descriptively.
Measured: one weeks follow-up
Prevalence of bacterial Rhinosinusitis
The number of patient with culture proven acute bacterial rhinosinusitis from samples of the middle meatus diagnosed by the JGG endoscope®
Measured: 2 weeks follow-up
Prevalence of any or deferred antibiotic prescriptions
The number of patients with any or deferred antibiotic prescriptions in patients with acute rhinosinusitis diagnosed by the JGG endoscope®
Measured: 2 weeks follow-up
Number of days with restrictions
The mean days with restrictions and symptoms from acute rhinosinusitis at Day 14 in patients with positive and negative cultures as diagnosed with the JGG endoscope®
Measured: 2 weeks follow-up
Patients's acceptability of JGG endoscope®
The patients' acceptability of the device will be assessed on Likert scale (If I would suffer again from an akute sinusitis, I would again agree being investigated with the JGG endoscope(R); possible answers 1: don't agree, 2: partially don't agree, 3: don't know, 4: partially agree, 5: agree). The findings will be presented descriptively.
Measured: one week follow-up
Physicians' acceptability by a global usefulness rating on Likert scales
The physicians' acceptability will be evaluated by a global usefulness rating on Likert scales with five categories after recruitment completion (The ratio of additional effort due to the JGG endoscope(R) and the newly gained information is good, possible answers 1: don't agree, 2: partially don't agree, 3: neutral, 4: partially agree, 5: agree). The findings will be presented descriptively.
Measured: 6 month
Prevalence of serious adverse events
The number of patients with any serious adverse event within the two weeks follow-up
Measured: 2 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start17 Dec 2018
- Primary completion31 May 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Bacterial SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective observational cohort study (single arm study)
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dominik Glinz
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland
- Responsible party
- Sponsor-investigator, Dominik Glinz, Basel Institute for Clinical Epidemiology and Biostatistics
- Investigators
- Heiner C Bucher, Prof., Principal investigator, CEB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766568
- Sponsor's protocol ID
- Sinus-Endo Study
- Acronym
- Sinus-Endo
- Status last verified
- Jan 2020
- First submitted
- 3 Dec 2018
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Glinz D, Georg Hansen J, Trutmann C, Schaller B, Vogt J, Diermayr C, Marti A, Leitmeyer K, Doerig P, Zeller A, Welge-Luessen Lemcke A, Bucher HC. Single-use device endoscopy for the diagnosis of acute bacterial rhinosinusitis in primary care: A pilot and feasibility study. Clin Otolaryngol. 2021 Sep;46(5):1050-1056. doi: 10.1111/coa.13785. Epub 2021 May 24.
PubMed 33866681
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Use Device Endoscopy for the Diagnosis of Acute Bacterial Rhinosinusitis in Primary Care: A Pilot and Feasibility Study
- ClinicalTrials.gov ID
- NCT03766568
- Acronym / sponsor ID
- Sinus-Endo / Sinus-Endo Study
- Conditions
- Acute Bacterial Sinusitis
- Keywords
- Rhinosinusitis, upper respiratory tract infection, antibiotic, endoscopy, Otolaryngology, primary care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dominik GlinzUniversity, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 6 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study to assess the first time use of the JGG endoscope® in humans and in primary care. The JGG endoscope® is attached to a Heine® otoscope and allows to inspect and to collect samples from the middle meatus of the sinus. The JGG endoscope® is sterile packaged, for one way use and disposable.
Detailed description
Acute rhinosinusitis is one of the most common reasons for consultations and antibiotic prescriptions in primary care although the condition is primarily of viral origin. The main reason for antibiotic overuse in acute rhinosinusitis is the lack of diagnostic tests of sufficient accuracy to confirm or rule out the diagnosis of acute bacterial rhinosinusitis (ABRS).
The gold standard for the diagnosis of ABRS is a bacterial culture from sinus maxillary puncture. This procedure is painful, prone to complications and only done in selected patients by oto-rhino-laryngology (ORL) specialists or for research purposes. Therefore, endoscopy of the middle meatus and collection of diagnostic material from the ostium draining the sinus is the diagnostic method of choice for ABRS and routinely used by ORL specialists in house and elsewhere. In patients with clinical symptoms of sufficient severity and duration (typically 5-10 days) for ABRS, endoscopy has a sensitivity of 85.7% (95% confidence interval, 56.2-97.5), specificity of 90.6% (73.8-97.5), positive predictive value of 80% (51.4-94.7), negative predictive value of 93.5% (77.2-98.9) for culture proven ABRS when compared with cultures gained from sinus puncture. Because of high upfront costs and logistical reason (disinfection) endoscopy is not used in general practice or internal medicine.
Dr. Jens G. Hansen has developed the disposable JGG endoscope® (JGG stands for the surnames of the inventor and his wife) which can be attached to the new generation of Heine® otoscopes with a LED light source that allows the inspection of the ostium in the middle meatus and collection of material for bacterial culture for the diagnosis of ABRS in primary care. After local anaesthesiology of the cavum nasi a sample material for cultures can be gained (earliest 10 min after local anaesthesia). The diagnostic procedure poses patients at minimal risk for complications and is of very little and short-termed discomfort.
In a pilot study the investigators would like to test the JGG endoscope® in 60 patients with suspected acute bacterial rhinosinusitis in the ORL unit of the University Hospital Basel and selected general practices that collaborate with the Centre for Primary Health Care of the University of Basel.
Objectives:
- To assess the feasibility of visualization and sample collection from the middle meatus with the JGG endoscope® in patients with clinically diagnosed acute bacterial rhinosinusitis in Swiss primary care setting
- to investigate whether the JGG endoscope® supports the decision of antibiotic prescribing
- to assess patients' and physicians' acceptability of the examination with the JGG endoscope®
- to investigate the prevalence of culture proven acute bacterial rhinosinusitis from samples of the middle meatus by the JGG endoscope® in patients with clinically diagnosed acute rhinosinusitis
- to investigate the number of patients with acute rhinosinusitis diagnosed by the JGG endoscope® with any and/or deferred antibiotic prescriptions
- to investigate the days with restrictions and symptoms in patients with acute rhinosinusitis with positive and negative bacterial cultures diagnosed by the JGG endoscope®
- to investigate any serious adverse event related to the JGG endoscope®.
Design Prospective observational cohort study (single arm study)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective observational cohort study (single arm study)
| Arm | Type | Receives |
|---|---|---|
| Diagnostic with JGG endoscope | Experimental | Device: JGG endoscope(R) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adults patients aged ≥18 years, with acute rhinosinusitis
- Duration: worsening of symptoms after 5 days after onset of symptoms or if symptoms persist for more than 10 days, but no longer than 28 days. In addition, Criteria 1 and 2 must be fulfilled.
- [Nasal blockage/obstruction/congestion OR Nasal Discharge (anterior/ posterior nasal drip)] AND [Facial pain/ pressure OR Reduction or loss of smell]
- Criteria 2 for acute bacterial rhinosinusitis
- discoloured discharge (unilateral predominance)
Key exclusion criteria (8 listed)
- Not being able to provide written informed consent in German (due to any mental or intellectual problem or other reasons)
- Not being available for follow-up
- Previous participation in Sinus-Endo study
- Use of antibiotic the last 4 weeks
- Known pathology or malformation of the sinuses or nasal cavity (like polyposis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JGG endoscope(R)The JGG endoscope(R) is attached to the new generation of Heine® otoscopes with a LED light source that allows the inspection of the ostium in the middle meatus and collection of material for bacterial culture for the diagnosis of ABRS in primary care. After local anaesthesiology of the cavum nasi a sample material for cultures can be gained (earliest 10 min after local anaesthesia). The diagnostic procedure poses patients at minimal risk for complications and is of very little and short-termed discomfort. | Device | Diagnostic with JGG endoscope |
Primary outcome
Prevalence of successful JGG endoscope® application
Time frame: Baseline Day 0
The number of patients with successful visualization and sample collection from the middle meatus with the JGG endoscope®
Prevalence of complications
Time frame: 2 weeks follow-up
The number of patients with complications related to the examination with the JGG endoscope®.
7 secondary outcomes
Influence of JGG endoscope® to support the decision of antibiotic prescribing
Time frame: one weeks follow-up
Prevalence of bacterial Rhinosinusitis
Time frame: 2 weeks follow-up
Prevalence of any or deferred antibiotic prescriptions
Time frame: 2 weeks follow-up
Number of days with restrictions
Time frame: 2 weeks follow-up
Patients's acceptability of JGG endoscope®
Time frame: one week follow-up
Physicians' acceptability by a global usefulness rating on Likert scales
Time frame: 6 month
Prevalence of serious adverse events
Time frame: 2 weeks follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Derived from this study: PubMed 33866681Glinz D, Georg Hansen J, Trutmann C, Schaller B, Vogt J, Diermayr C, Marti A, Leitmeyer K, Doerig P, Zeller A, Welge-Luessen Lemcke A, Bucher HC. Single-use device endoscopy for the diagnosis of acute bacterial rhinosinusitis in primary care: A pilot and feasibility study. Clin Otolaryngol. 2021 Sep;46(5):1050-1056. doi: 10.1111/coa.13785. Epub 2021 May 24.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heiner C Bucher, Prof. principal investigator
CEB
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JGG endoscope(R) in people with Acute Bacterial Sinusitis, run by Dominik Glinz at 6 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominik Glinz, Dr. sc. (+41 61 328 54 02, dominik.glinz@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of successful JGG endoscope® application (time frame: Baseline Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03766568, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.