Deviated Nasal SeptumSSLENCT00957502
ENTact™ Septal Stapler Shelf Life Extension
A study testing ENTact™ Septal Stapler in people with Deviated Nasal Septum, run by ENTrigue Surgical, Inc. at 1 site in United States.
Trial summary
This study is a prospective, limited-use evaluation of the ENTact™ Septal Stapler for tissue approximation utilizing staples with extended shelf life. The ENTact™ Septal Stapler will be used to approximate the mucoperichondrial flaps in all patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Deviated Nasal Septum
- What is being tested?
- ENTact™ Septal Stapler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Feb 2010
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients, between the ages of 18 and 65 years, with a clinically significant deviation of the nasal septum.
- Patient is able to provide a signed informed consent form.
- Patient will agree to comply with all study related procedures.
- Subject is not pregnant at this time by confirmation of one of the following:
- subject is male,
- subject not of child bearing age,
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- subject is surgically sterile,
- subject is not pregnant per negative hCG test.
- Subject does not plan on becoming pregnant and is not breast feeding during the course of the study.
Who cannot join
- Patients who have had previous septoplasty
- Patients with uncontrolled diabetes
- Presence of infection at the study site
- Subject is a:
- smoker,
- severe drug abuser,
- severe alcohol abuser.
- Patient with autoimmune disease deemed clinically significant by the Principal Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Limited-Use Evaluation of the ENTact™ Septal Stapler for Tissue Approximation Utilizing Staples With Extended Shelf Life
This study is a prospective, limited-use evaluation of the ENTact™ Septal Stapler for tissue approximation utilizing staples with extended shelf life. The ENTact™ Septal Stapler will be used to approximate the mucoperichondrial flaps in all patients. Each treatment group will be implanted with product that has been aged for a specified amount of time.
- Conditions
- Deviated Nasal Septum
- Being tested
- ENTact™ Septal Stapler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENTact™ Septal StaplerDevice
1 year aged septal staples
ENTact™ Septal StaplerDevice
18 Month Aged Staples
| Study group | Role | What they receive |
|---|---|---|
| One year aged staples | Experimental | Subjects implanted with sterile staples aged to approximately one year. Receives: Device: ENTact™ Septal Stapler |
| 18 month aged staples | Experimental | Subjects implanted with sterile staples aged to approximately 18 months. Receives: Device: ENTact™ Septal Stapler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance of aged ENTact™ Septal Staples
Measured: One week post op
Secondary outcomes (2)
Clinical evaluation of gross tissue appearance at implantation site(s)
Measured: One week post op
ENTact™ Septal Staple functionality based on maintained coaptation
Measured: One week post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deviated Nasal SeptumStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- ENTrigue Surgical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas A Tami, MD, Principal investigator, Good Samaritan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957502
- Sponsor's protocol ID
- CSA2009-03
- Acronym
- SSLE
- Status last verified
- Aug 2012
- First submitted
- 10 Aug 2009
- Last updated
- 23 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Limited-Use Evaluation of the ENTact™ Septal Stapler for Tissue Approximation Utilizing Staples With Extended Shelf Life
- ClinicalTrials.gov ID
- NCT00957502
- Acronym / sponsor ID
- SSLE / CSA2009-03
- Conditions
- Deviated Nasal Septum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- ENTrigue Surgical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 12 Aug 2009 (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.
This study is a prospective, limited-use evaluation of the ENTact™ Septal Stapler for tissue approximation utilizing staples with extended shelf life. The ENTact™ Septal Stapler will be used to approximate the mucoperichondrial flaps in all patients. Each treatment group will be implanted with product that has been aged for a specified amount of time.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One year aged staples | Experimental | Device: ENTact™ Septal StaplerSubjects implanted with sterile staples aged to approximately one year. |
| 18 month aged staples | Experimental | Device: ENTact™ Septal StaplerSubjects implanted with sterile staples aged to approximately 18 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult patients, between the ages of 18 and 65 years, with a clinically significant deviation of the nasal septum.
- Patient is able to provide a signed informed consent form.
- Patient will agree to comply with all study related procedures.
- Subject is not pregnant at this time by confirmation of one of the following:
- Subject does not plan on becoming pregnant and is not breast feeding during the course of the study.
Key exclusion criteria (8 listed)
- Patients who have had previous septoplasty
- Patients with uncontrolled diabetes
- Presence of infection at the study site
- Subject is a:
- Patient with autoimmune disease deemed clinically significant by the Principal Investigator.
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 |
|---|---|---|
| ENTact™ Septal Stapler1 year aged septal staples | Device | One year aged staples |
| ENTact™ Septal Stapler18 Month Aged Staples | Device | 18 month aged staples |
Primary outcome
Clinical performance of aged ENTact™ Septal Staples
Time frame: One week post op
2 secondary outcomes
Clinical evaluation of gross tissue appearance at implantation site(s)
Time frame: One week post op
ENTact™ Septal Staple functionality based on maintained coaptation
Time frame: One week post op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 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.
Thomas A Tami, MD principal investigator
Good Samaritan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENTact™ Septal Stapler in people with Deviated Nasal Septum, run by ENTrigue Surgical, 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 9 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: finished, as of the sponsor's last update on 23 Aug 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical performance of aged ENTact™ Septal Staples (time frame: One week post op). 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 23 Aug 2012.