SinusitisNCT01115309
XprESS Registry Study
A study testing XprESS Balloon Device in people with Sinusitis, run by Entellus Medical, Inc. at 1 site in United States.
Trial summary
This is a prospective, non-randomized, multi-center study to assess safety and long-term patency of the ostia treated with the XprESS device per the device indication for use (IFU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinusitis
- What is being tested?
- XprESS Balloon Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 18 years of age or older
- Scheduled to undergo sinus surgery with planned use of the XprESS Balloon Device consistent with the tool's Indication for Use
- Willing and able to provide consent
Who cannot join
- Known Samter's Triad
- History of primary ciliary dysfunction
- History of cystic fibrosis
- Known to be immunosuppressed
- Hemophilia
- Currently enrolled in another pre-approval investigational study
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective, non-randomized, multi-center study to assess safety and long-term patency of the ostia treated with the XprESS device per the device indication for use (IFU).
Read the detailed description
Endoscopic balloon-only and hybrid-balloon procedures involving dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia were performed in 175 patients.
One-month follow-up was required for all patients. The first 50 patients enrolled also consented to a 1-year follow-up. Complications and sinus symptom severity were assessed at the 1-month visit. Symptom severity and ostial patency of the treated sinuses were evaluated at the 1-year visit.
- Conditions
- Sinusitis
- Being tested
- XprESS Balloon Device
- Keywords
- Sinusitis
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XprESS Balloon DeviceDevice
Sinus dilation completed with the XprESS Balloon Device with or without additional endoscopic sinus surgery procedures (dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia).
| Study group | Role | What they receive |
|---|---|---|
| XprESS Balloon Device | Other | Sinus dilation Receives: Device: XprESS Balloon Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Assessments
Adverse event reporting as related to XprESS device or procedure
Measured: 1 month after procedure
Secondary outcomes (3)
Sino-Nasal Outcome Test (SNOT-20) at 1 Month
The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20.
Measured: Baseline and 1 month after procedure
SNOT-20 at 6 Months
The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20.
Measured: Baseline and 6 months post procedure
SNOT-20 at 12 Months
The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20.
Measured: Baseline and 12 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Entellus Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeff Grebner, Study chair, Entellus Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115309
- Sponsor's protocol ID
- 1677-001
- Status last verified
- Oct 2020
- First submitted
- 29 Apr 2010
- Last updated
- 27 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Brodner D, Nachlas N, Mock P, Truitt T, Armstrong M, Pasha R, Jung C, Atkins J. Safety and outcomes following hybrid balloon and balloon-only procedures using a multifunction, multisinus balloon dilation tool. Int Forum Allergy Rhinol. 2013 Aug;3(8):652-8. doi: 10.1002/alr.21156. Epub 2013 Feb 19.
PubMed 23424023
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- XprESS Registry Study
- ClinicalTrials.gov ID
- NCT01115309
- Acronym / sponsor ID
- 1677-001
- Conditions
- Sinusitis
- Keywords
- Sinusitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Entellus Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 May 2010 (estimated)
- Results
- Posted 8 Oct 2020
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 prospective, non-randomized, multi-center study to assess safety and long-term patency of the ostia treated with the XprESS device per the device indication for use (IFU).
Detailed description
Endoscopic balloon-only and hybrid-balloon procedures involving dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia were performed in 175 patients.
One-month follow-up was required for all patients. The first 50 patients enrolled also consented to a 1-year follow-up. Complications and sinus symptom severity were assessed at the 1-month visit. Symptom severity and ostial patency of the treated sinuses were evaluated at the 1-year visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XprESS Balloon Device | Other | Device: XprESS Balloon DeviceSinus dilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Scheduled to undergo sinus surgery with planned use of the XprESS Balloon Device consistent with the tool's Indication for Use
- Willing and able to provide consent
Key exclusion criteria (6 listed)
- Known Samter's Triad
- History of primary ciliary dysfunction
- History of cystic fibrosis
- Known to be immunosuppressed
- Hemophilia
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 |
|---|---|---|
| XprESS Balloon DeviceSinus dilation completed with the XprESS Balloon Device with or without additional endoscopic sinus surgery procedures (dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia). | Device | XprESS Balloon Device |
Primary outcome
Safety Assessments
Time frame: 1 month after procedure
Adverse event reporting as related to XprESS device or procedure
3 secondary outcomes
Sino-Nasal Outcome Test (SNOT-20) at 1 Month
Time frame: Baseline and 1 month after procedure
SNOT-20 at 6 Months
Time frame: Baseline and 6 months post procedure
SNOT-20 at 12 Months
Time frame: Baseline and 12 months post procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23424023Brodner D, Nachlas N, Mock P, Truitt T, Armstrong M, Pasha R, Jung C, Atkins J. Safety and outcomes following hybrid balloon and balloon-only procedures using a multifunction, multisinus balloon dilation tool. Int Forum Allergy Rhinol. 2013 Aug;3(8):652-8. doi: 10.1002/alr.21156. Epub 2013 Feb 19.
- Individual participant dataSharing planned: No
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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.
Jeff Grebner study chair
Entellus Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XprESS Balloon Device in people with Sinusitis, run by Entellus Medical, Inc. at 1 site in United States.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 8 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Assessments (time frame: 1 month after procedure). 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 NCT01115309, 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 27 Oct 2020.