Chronic SinusitisPhase 4NCT00671541
Nasospore Stent For Use in Enodscopic Sinus Surgery
A Phase 4 study testing Merogel Nasal Stent and Nasopore Stent and Nasopore Stent and either Gentamycin or Bacitracin in people with Chronic Sinusitis, run by Lahey Clinic at 1 site in United States.
Trial summary
The purpose of this study is to evaluate a stenting material called Nasopore. This is a synthetic material approved by FDA for use as a stent in postoperative sinus surgery patients. This study will compare the Nasopore stent to other approved stenting materials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Sinusitis
- What is being tested?
- Merogel Nasal Stent and Nasopore Stent and Nasopore Stent and either Gentamycin or Bacitracin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Feb 2012
- Phase
- Phase 4
- 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
- Evaluation by Otolaryngologist \& determined to need endoscopic sinus surgery
- Only subjects with Bilateral disease
Who cannot join
- Pediatric subjects(under the age of 18)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nasospore Stent For The Use in Endoscopic Sinus Surgery
The purpose of this study is to evaluate a stenting material called Nasopore. This is a synthetic material approved by FDA for use as a stent in postoperative sinus surgery patients. This study will compare the Nasopore stent to other approved stenting materials.
Read the detailed description
This study will compare other sinus stenting products to the Nasopore stent. The stents will be soaked in antibiotic solutions and be observed for how well they perform. Subjects will have a stent placed in each sinus, stents may be the standard antibiotic saturated materials or the new nasopore material or nasopore stent soaked in antibiotics.
- Conditions
- Chronic Sinusitis
- Being tested
- Merogel Nasal Stent and Nasopore Stent, Nasopore Stent and either Gentamycin or Bacitracin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Merogel Nasal Stent and Nasopore StentDrug
Also called Merogel Stent, Nasopore Stent, Bacatracin soaked stent, Gentamicin soaked stent
Merogel Nasal Stent and Nasopore Stent
Nasopore Stent and either Gentamycin or BacitracinDrug
Also called Merogel Stent, Nasopore Stent, Bacatracin soaked stent, Gentamicin soaked stent
Nasopore Stent with Bacitracin (100,000 units in 10cc(NSS)or Gentamycin(80mg in 10cc NSS)
| Study group | Role | What they receive |
|---|---|---|
| Merogel stent vs. Nasopore Stent | Active comparator | This study has two arms consiting of 50 subjects each (100 total) Arm 1 will recieve the standard stent (merogel)in their right sinus and a nasopore stent in their left sinus. Receives: Drug: Merogel Nasal Stent and Nasopore Stent |
| bacitracin vs. gentamicin treated stent | Experimental | The second arm will consist of 50 new subjects. These 50 subjects will have a nasopore stent placed in the left sinus. The first 25 subjects will have nasopore stent placed postoperatively with a bacitracin soaked nasopore in right sinus the second 25 will have a gentamycin soaked nasopore stent in right sinus. Receives: Drug: Merogel Nasal Stent and Nasopore Stent; Drug: Nasopore Stent and either Gentamycin or Bacitracin |
What is being measured
The primary outcome is the main question the study is designed to answer.
This study will evaluate the efficacy of nasopore stent soaked in bacitracin in and one stent soaked in gentaymcin antibiotic solution
Measured: prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2008 (estimated)
- Study startMar 2006
- Primary completionFeb 2012
- Study completionFeb 2012
Why it stopped: Principal Investigator left the institution requested study terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter J. Catalano, MD, Principal investigator, Lahey Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00671541
- Sponsor's protocol ID
- LCID 2006-026
- Status last verified
- Feb 2012
- First submitted
- 1 May 2008
- Last updated
- 17 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasospore Stent For The Use in Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT00671541
- Acronym / sponsor ID
- LCID 2006-026
- Conditions
- Chronic Sinusitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal Investigator left the institution requested study terminated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 5 May 2008 (estimated)
- 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.
The purpose of this study is to evaluate a stenting material called Nasopore. This is a synthetic material approved by FDA for use as a stent in postoperative sinus surgery patients. This study will compare the Nasopore stent to other approved stenting materials.
Detailed description
This study will compare other sinus stenting products to the Nasopore stent. The stents will be soaked in antibiotic solutions and be observed for how well they perform. Subjects will have a stent placed in each sinus, stents may be the standard antibiotic saturated materials or the new nasopore material or nasopore stent soaked in antibiotics.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Merogel stent vs. Nasopore Stent | Active comparator | Drug: Merogel Nasal Stent and Nasopore StentThis study has two arms consiting of 50 subjects each (100 total) Arm 1 will recieve the standard stent (merogel)in their right sinus and a nasopore stent in their left sinus. |
| bacitracin vs. gentamicin treated stent | Experimental | Drug: Merogel Nasal Stent and Nasopore Stent, Drug: Nasopore Stent and either Gentamycin or BacitracinThe second arm will consist of 50 new subjects. These 50 subjects will have a nasopore stent placed in the left sinus. The first 25 subjects will have nasopore stent placed postoperatively with a bacitracin soaked nasopore in right sinus the second 25 will have a gentamycin soaked nasopore stent in right sinus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Evaluation by Otolaryngologist \& determined to need endoscopic sinus surgery
- Only subjects with Bilateral disease
Key exclusion criteria (1 listed)
- Pediatric subjects(under the age of 18)
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 |
|---|---|---|
| Merogel Nasal Stent and Nasopore StentAlso: Merogel Stent, Nasopore Stent, Bacatracin soaked stent, Gentamicin soaked stentMerogel Nasal Stent and Nasopore Stent | Drug | Merogel stent vs. Nasopore Stent, bacitracin vs. gentamicin treated stent |
| Nasopore Stent and either Gentamycin or BacitracinAlso: Merogel Stent, Nasopore Stent, Bacatracin soaked stent, Gentamicin soaked stentNasopore Stent with Bacitracin (100,000 units in 10cc(NSS)or Gentamycin(80mg in 10cc NSS) | Drug | bacitracin vs. gentamicin treated stent |
Primary outcome
This study will evaluate the efficacy of nasopore stent soaked in bacitracin in and one stent soaked in gentaymcin antibiotic solution
Time frame: prospective
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2012.
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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.
Peter J. Catalano, MD principal investigator
Lahey Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Merogel Nasal Stent and Nasopore Stent and Nasopore Stent and either Gentamycin or Bacitracin in people with Chronic Sinusitis, run by Lahey Clinic 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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 17 Feb 2012. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
This study will evaluate the efficacy of nasopore stent soaked in bacitracin in and one stent soaked in gentaymcin antibiotic solution (time frame: prospective). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2012.