Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Advance Research Associates | OTHER |
Not provided
Not provided
Not provided
Not provided
The objective of the PROGRESS Study is to assess the safety and efficacy of the Propel Mini and Propel Nova steroid-eluting Sinus Implants when placed in the frontal sinus opening following frontal sinus surgery in patients with chronic sinusitis.
This is a prospective, randomized, blinded, controlled, multicenter study enrolling two consecutive cohorts of up to 80 patients each (Propel Mini cohort followed by Propel Nova cohort). The study patients will undergo implant placement on one side following ESS that includes bilateral frontal sinus surgery by traditional surgical technique or balloon dilation.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PROPEL Mini Sinus Implant | Experimental | Propel Mini placed in frontal sinus opening following ESS |
|
| Sinus Surgery alone: cohort 1 | Active Comparator | Sinus Surgery only: cohort 1: ESS with standard post-operative care. |
|
| PROPEL Nova Sinus Implant | Experimental | Propel Nova placed in frontal sinus opening following ESS |
|
| Sinus Surgery alone: cohort 2 | Active Comparator | Sinus Surgery only: cohort 2: ESS with standard post-operative care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROPEL Mini Sinus Implant. | Device | Placement of sinus implant following frontal sinus surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Sinuses That Require Post-operative Interventions (Propel Mini Cohort) | The reduction in need for post-operative interventions at Day 30, as determined by an independent blinded sinus surgeon based on video-endoscopy reviews. Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the Frontal sinus opening(defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response). | Day 30 |
| Percent of Sinuses That Require Post-operative Interventions (Propel Nova Cohort) | The reduction in need for post-operative interventions at Day 30, as determined by an independent blinded sinus surgeon based on video-endoscopy reviews. Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the Frontal sinus opening(defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response). | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Need for Post-operative Interventions (Propel Mini Cohort) | Need for post-operative interventions by clinical investigators at Day 30 Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the FSO (defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Timothy L. Smith, MD, MPH | Oregon Health and Science University | Principal Investigator |
| Amber U. Luong, MD, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sacramento Ear, Nose and Throat | Sacramento | California | 95815 | United States | ||
| Breathe Clear Institute of Sinus and Allergy Relief |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27363723 | Result | Smith TL, Singh A, Luong A, Ow RA, Shotts SD, Sautter NB, Han JK, Stambaugh J, Raman A. Randomized controlled trial of a bioabsorbable steroid-releasing implant in the frontal sinus opening. Laryngoscope. 2016 Dec;126(12):2659-2664. doi: 10.1002/lary.26140. Epub 2016 Jul 1. | |
| 29098299 | Derived | Luong A, Ow RA, Singh A, Weiss RL, Han JK, Gerencer R, Stolovitzky JP, Stambaugh JW, Raman A. Safety and Effectiveness of a Bioabsorbable Steroid-Releasing Implant for the Paranasal Sinus Ostia: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2018 Jan;144(1):28-35. doi: 10.1001/jamaoto.2017.1859. Epub 2017 Nov 2. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PROPEL Mini Sinus Implant | This study will use an intra-patient design. Each patient will undergo placement of one implant. The untreated side will represent the control. The side of placement will be randomly assigned. PROPEL Mini Sinus Implant: Placement of sinus implant following frontal sinus surgery |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Intra-patient control
Not provided
Not provided
Not provided
| Sinus Surgery alone | Procedure | Sinus surgery only, without implant placement |
|
| Propel Nova Sinus Implant | Device | Placement of sinus implant following frontal sinus surgery |
|
|
| Day 30 |
| Need for Surgical Interventions (Propel Mini Cohort) | Need for Surgical Interventions by clinical investigators at Day 30. Need for surgical interventions was prospectively defined as Adhesion/scarring grades of 2 and 3. Adhesions/Scarring was assessed based on a 4-point scale as follows: 0= No visible granulation/scarring in the FSO
| Day 30 |
| Inflammation (Propel Mini Cohort) | The degree of inflammation present in the frontal recess/FSO was evaluated by clinical investigators using a 100-mm VAS ranging from 0 defined as no visible inflammation to 100 defined as severe inflammation, involving extensive erythema, edema, or polyposis. | Day 30 |
| Occlusion/Restenosis (Propel Mini Cohort) | Patency of the FSO was assessed by clinical investigators endoscopically on a 3-point grading scale as follows: 0=Patent
| Day 30 |
| Need for Post-operative Interventions (Propel Nova Cohort) | Need for post-operative interventions by clinical investigators at Day 30. Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the FSO (defined as grade 2 or 3 on the adhesion/scarring scale by investigators), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response). | Day 30 |
| Need for Surgical Interventions (Propel Nova Cohort) | Need for Surgical Interventions by clinical investigators at Day 30 Need for Surgical Interventions by clinical investigators at Day 30. Need for surgical interventions was prospectively defined as Adhesion/scarring grades of 2 and 3. Adhesions/Scarring was assessed based on a 4-point scale as follows: 0= No visible granulation/scarring in the FSO
| Day 30 |
| Inflammation (Propel Nova Cohort) | The degree of inflammation present in the frontal recess/FSO was evaluated by clinical investigators using a 100-mm VAS ranging from 0 defined as no visible inflammation to 100 defined as severe inflammation, involving extensive erythema, edema, or polyposis. | Day 30 |
| Occlusion/Restenosis (Propel Nova Cohort) | Patency of the FSO was assessed by clinical investigators endoscopically on a 3-point grading scale as follows: 0=Patent
| Day 30 |
| Torrance |
| California |
| 90503 |
| United States |
| The Connecticut Center for Advanced ENT Care | Norwalk | Connecticut | 06851 | United States |
| George Washington University Medical Faculty Associates | Washington D.C. | District of Columbia | 20006 | United States |
| ENT of Georgia | Atlanta | Georgia | 30342 | United States |
| Advanced ENT and Allergy | Louisville | Kentucky | 40207 | United States |
| Albany ENT and Allergy | Albany | New York | 12206 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| East Virginia Medical School | Norfolk | Virginia | 23507 | United States |
| PROPEL Nova Sinus Implant |
This study will use an intra-patient design. Each patient will undergo placement of one implant. The untreated side will represent the control. The side of placement will be randomly assigned. PROPEL Nova Sinus Implant: Placement of sinus implant following frontal sinus surgery |
| COMPLETED |
|
| NOT COMPLETED |
|
This is an intra-patient design where one sinus side of the patient is randomized to receive the treatment while the contralateral sinus side acts as the control.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PROPEL Mini Sinus Implant and No Implant Cohort 1 | This study will use an intra-patient design. Each patient will undergo placement of one implant. The untreated side will represent the control. The side of placement will be randomly assigned. PROPEL Mini or Nova Sinus Implant.: Placement of sinus implant following frontal sinus surgery |
| BG001 | PROPEL Nova Sinus Implant and No Implant Cohort 2 | This study will use an intra-patient design. Each patient will undergo placement of one implant. The untreated side will represent the control. The side of placement will be randomly assigned. PROPEL Mini or Nova Sinus Implant.: Placement of sinus implant following frontal sinus surgery |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Percent of Sinuses That Require Post-operative Interventions (Propel Mini Cohort) | The reduction in need for post-operative interventions at Day 30, as determined by an independent blinded sinus surgeon based on video-endoscopy reviews. Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the Frontal sinus opening(defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response). | ITT population | Posted | Number | 95% Confidence Interval | percent sinuses requiring intervention | Day 30 |
|
|
| ||||||||||||||||||||||||||||
| Primary | Percent of Sinuses That Require Post-operative Interventions (Propel Nova Cohort) | The reduction in need for post-operative interventions at Day 30, as determined by an independent blinded sinus surgeon based on video-endoscopy reviews. Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the Frontal sinus opening(defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response). | Of the 80 patients who had their endoscopy recorded at day 30 for grading by independent reviewer; 19 patients could not be included in the test due to missing data. Data were considered missing if the independent reviewer could not grade a video on one or both treatment sinus sides. | Posted | Number | 95% Confidence Interval | percentage sinus requiring intervention | Day 30 |
| ||||||||||||||||||||||||||||||
| Secondary | Need for Post-operative Interventions (Propel Mini Cohort) | Need for post-operative interventions by clinical investigators at Day 30 Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the FSO (defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response). | Posted | Number | 95% Confidence Interval | percentage of evaluable sinuses | Day 30 | sinus sides | sinus sides |
|
| ||||||||||||||||||||||||||||
| Secondary | Need for Surgical Interventions (Propel Mini Cohort) | Need for Surgical Interventions by clinical investigators at Day 30. Need for surgical interventions was prospectively defined as Adhesion/scarring grades of 2 and 3. Adhesions/Scarring was assessed based on a 4-point scale as follows: 0= No visible granulation/scarring in the FSO
| Posted | Number | percentage of evaluable sinuses | Day 30 | sinus sides | sinus sides |
|
| |||||||||||||||||||||||||||||
| Secondary | Inflammation (Propel Mini Cohort) | The degree of inflammation present in the frontal recess/FSO was evaluated by clinical investigators using a 100-mm VAS ranging from 0 defined as no visible inflammation to 100 defined as severe inflammation, involving extensive erythema, edema, or polyposis. | Posted | Mean | Standard Deviation | 100-mm VAS | Day 30 | sinus sides | sinus sides |
|
| ||||||||||||||||||||||||||||
| Secondary | Occlusion/Restenosis (Propel Mini Cohort) | Patency of the FSO was assessed by clinical investigators endoscopically on a 3-point grading scale as follows: 0=Patent
| Posted | Number | 95% Confidence Interval | percentage of evaluable sinuses | Day 30 | sinus sides | sinus sides |
|
| ||||||||||||||||||||||||||||
| Secondary | Need for Post-operative Interventions (Propel Nova Cohort) | Need for post-operative interventions by clinical investigators at Day 30. Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the FSO (defined as grade 2 or 3 on the adhesion/scarring scale by investigators), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response). | Posted | Number | 95% Confidence Interval | percentage of evaluable sinuses | Day 30 | sinus sides | sinus sides |
|
| ||||||||||||||||||||||||||||
| Secondary | Need for Surgical Interventions (Propel Nova Cohort) | Need for Surgical Interventions by clinical investigators at Day 30 Need for Surgical Interventions by clinical investigators at Day 30. Need for surgical interventions was prospectively defined as Adhesion/scarring grades of 2 and 3. Adhesions/Scarring was assessed based on a 4-point scale as follows: 0= No visible granulation/scarring in the FSO
| Posted | Number | percentage of evaluable sinuses | Day 30 | sinus sides | sinus sides |
|
| |||||||||||||||||||||||||||||
| Secondary | Inflammation (Propel Nova Cohort) | The degree of inflammation present in the frontal recess/FSO was evaluated by clinical investigators using a 100-mm VAS ranging from 0 defined as no visible inflammation to 100 defined as severe inflammation, involving extensive erythema, edema, or polyposis. | Posted | Mean | Standard Deviation | 100-mm VAS | Day 30 | sinus sides | sinus sides |
|
| ||||||||||||||||||||||||||||
| Secondary | Occlusion/Restenosis (Propel Nova Cohort) | Patency of the FSO was assessed by clinical investigators endoscopically on a 3-point grading scale as follows: 0=Patent
| Posted | Number | 95% Confidence Interval | percentage of evaluable sinuses | Day 30 | sinus sides | sinus sides |
|
|
Propel Mini cohort: 90 days
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 | PROPEL Mini Sinus Implant | Propel Mini placed in frontal sinus opening following ESS PROPEL Mini Sinus Implant.: Placement of sinus implant following frontal sinus surgery | 3 | 80 | 43 | 80 | ||
| EG001 | PROPEL Nova Sinus Implant | Propel Nova placed in frontal sinus opening following ESS PROPEL Nova Sinus Implant.: Placement of sinus implant following frontal sinus surgery | 1 | 80 | 36 | 80 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular Accident | Vascular disorders | MedDRA 17.0 | Systematic Assessment | not device-related |
|
| Diverticulitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment | not device related |
|
| Respiratory tract infection fungal | Infections and infestations | MedDRA 17.0 | Systematic Assessment | not device related |
|
| deep vein thrombosis | Vascular disorders | MedDRA 17.0 | Systematic Assessment | not device related |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| acute sinusitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment | not device related |
|
| chronic sinusitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment | not device related |
|
| upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment | not device related |
|
| headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment | not device related |
|
| presyncope | Nervous system disorders | MedDRA 17.0 | Systematic Assessment | not device related |
|
| epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment | not device related |
|
| asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Stambaugh (VP, Clinical Affairs) | Intersect ENT | 650-641-2103 | jstambaugh@intersectent.com |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
| sinus sides |
|
|
| Participants |
|
| sinus sides |
|
|
| sinus sides |
|
|
| sinus sides |
|
|
| Counts |
|---|
| Participants |
|
| sinus sides |
|
|
| Participants |
|
| sinus sides |
|
|
| sinus sides |
|
|
| sinus sides |
|
|