Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Intersect ENT | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Randomized, controlled, blinded clinical trial with 40 patients randomized in a 1:1 ratio to either treatment (bilateral in-office placement of a drug-eluting implant in the ethmoid sinuses following ethmoidectomy) or control (post-op standard of care) group and followed for 6 months.
This prospective, randomized, controlled, blinded trial aimed to assess the efficacy of a drug-eluting sinus implant placed following ethmoidectomy in addition to post-op standard of care, including debridement, irrigation, and topical steroids, compared to the same standard of care alone (control). Patients returned for follow-up examination at 2 weeks and again at 1, 3 and 6 months after placement. Follow-up examination consisted of patient-reported outcomes and endoscopic grading by clinical investigators and an independent sinus surgeon based on a centralized, blinded video-endoscopy review.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Bilateral in-office placement of a steroid-eluting sinus implant following ethmoidectomy in addition to post-op standard of care, including debridement, irrigation, and topical steroids |
|
| Control | Active Comparator | Post-op standard of care, including debridement, irrigation, and topical steroids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Steroid-eluting sinus implant | Combination Product | PROPEL (Intersect ENT, Inc., Menlo Park, CA), containing 370μg of mometasone furoate gradually released over 30 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inflammation Score | Inflammation score was determined at baseline and Day 90 using a visual analogue scale (VAS), ranging from 0 (no visible inflammation) to 100 (severe inflammation, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes), as determined by an independent sinus surgeon based on a centralized, blinded video-endoscopy review. | Change from baseline to Day 90 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Keith E Matheny, MD | Collin County Ear Nose & Throat | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Collin County Ear Nose & Throat | Frisco | Texas | 75034 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Participants underwent endoscopic sinus surgery, including bilateral ethmoidectomy with middle meatal antrostomy. Concurrent septoplasty and surgical treatment of the other paranasal sinuses were also permitted. Participants returned at 7 days post-op and those meeting final eligibility underwent baseline assessment and group assignment.
A total of 45 patients were recruited at one clinical site between November 9, 2015 and May 24, 2016, of whom 40 met final eligibility.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sinus Implant+Post-op Standard of Care | Bilateral in-office placement a steroid-eluting sinus implant in the ethmoid sinuses in addition to post-op standard of care, including debridement, irrigation, and topical steroids |
| FG001 | Post-op Standard of Care | Post-op standard of care, including debridement, irrigation, and topical steroids |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-treat population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Steroid-eluting sinus implant placement following ethmoidectomy in addition to post-op standard of care (i.e. debridement, irrigation, and topical steroids) |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Inflammation Score | Inflammation score was determined at baseline and Day 90 using a visual analogue scale (VAS), ranging from 0 (no visible inflammation) to 100 (severe inflammation, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes), as determined by an independent sinus surgeon based on a centralized, blinded video-endoscopy review. | Intent-to-treat population (all randomized participants). Values adjusted for any surgical or steroid intervention by caring forward last observation before intervention. Scores for 9 participants (7 treatment, 2 control) were missing because the video-endoscopies for those participants had insufficient content to allow grading. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to Day 90 |
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | Bilateral in-office placement of a steroid-eluting sinus implant following ethmoidectomy in addition to post-op standard of care, including debridement, irrigation, and topical steroids |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pelvic abscess | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment | Patient was hospitalized for pelvic abscess following hysterectomy. The event was judged unrelated to the steroid-eluting sinus implant or placement procedure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinusitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keith E Matheny, MD (Principal Investigator) | Collin County ENT | (972) 596-4005 | kmatheny618@gmail.com |
Not provided
| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| D003646 | Debridement |
| D007507 | Therapeutic Irrigation |
| D013256 | Steroids |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Patients assigned to the treatment group underwent a bilateral in-office placement of a steroid-eluting sinus implant 7 days following ethmoidectomy in addition to post-op standard of care, including debridement, irrigation, and topical steroids. Patients randomized to the control group received same standard of care alone.
Not provided
Not provided
Patients were wearing eye masked and noise-cancelling headsets during placement and follow-up endoscopies.
The primary outcome was assessed by an independent sinus surgeon based on a centralized, blinded video-endoscopy review.
|
| Post-op standard of care | Other | Post-op standard of care including debridement, irrigation, and/or topical steroids |
|
|
Post-op standard of care (i.e. debridement, irrigation, and topical steroids)
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Number of prior ESS | Prior endoscopic sinus surgery procedures | Count of Participants | Participants |
|
| History of asthma diagnosed by physician | Count of Participants | Participants |
|
| History of allergic rhinitis diagnosed by physician | Count of Participants | Participants |
|
| History of allergies | Count of Participants | Participants |
|
| History of aspirin exacerbated respiratory disease (AERD) | Count of Participants | Participants |
|
| History of smoking | Count of Participants | Participants |
|
| OG001 | Post-op Standard of Care | Post-op standard of care, including debridement, irrigation, and topical steroids |
|
|
|
| 0 |
| 20 |
| 2 |
| 20 |
| 6 |
| 20 |
| EG001 | Control | Post-op standard of care, including debridement, irrigation, and topical steroids | 0 | 20 | 1 | 20 | 4 | 20 |
|
| Myocardial Infarction | Cardiac disorders | MedDRA (17.0) | Systematic Assessment | Participant had pre-existent cardiac disease. The event was determined to be unrelated to the steroid-eluting implant or placement procedure |
|
| Synechiae nose | Surgical and medical procedures | MedDRA (17.0) | Systematic Assessment | Synechiae resulting from the middle turbinate lateralization requiring intervention. |
|
| Congestion chest | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment | Participant complained of chest congestion |
|
| Congestion nasal | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Allergy aggravated | Immune system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Cellulitis nasal | Infections and infestations | MedDRA (17.0) | Systematic Assessment | Cellulitis inside right nasal vestibule treated with antibiotics |
|
| Sinus polyp | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Pain ear | Ear and labyrinth disorders | MedDRA (17.0) | Systematic Assessment | Participant complained of ear pain. It was judged to be unrelated to the steroid-eluting sinus implant. |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
Not provided
Not provided
| D011083 |
| Polycyclic Compounds |
| D013514 | Surgical Procedures, Operative |
| D006875 | Hydrotherapy |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D008919 | Investigative Techniques |