Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Tivic Health Systems | INDUSTRY |
Not provided
Not provided
Not provided
The purpose of this study is to investigate whether daily use of a microcurrent neuromodulation device, which applies a small current of electricity to the forehead and maxillary region, will decrease the pain experienced by patients in the days following functional endoscopic sinus surgery (FESS). This study is a prospective randomized controlled study. Enrolled subjects will be randomized (1:1) to receive either an active neuromodulation study device or a sham device that appears identical to the active device while emitting no therapeutic microcurrent. Subjects will self-treat with the device at home and will be followed for 2 weeks after FESS.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microcurrent TENS device | Experimental | A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region |
|
| Sham device | Sham Comparator | The sham device appears identical to the active device while emitting no therapeutic microcurrent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microcurrent TENS device | Device | The study device is a handheld micro-current TENS emitter intended to be used for the relief of postoperative pain after FESS. The design of the study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated with the sinuses. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Visual Analog Score After First Use of Device | Change in postoperative pain score in first use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. Participants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the first time they use the device. | baseline, 10 min, 2 hour, 4 hour at first use within 14 days after procedure |
| Change in Pain Visual Analog Score After Second Use of Device | Change in postoperative pain score after second use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. Participants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the second time they use the device. | baseline, 10 min, 2 hour, 4 hour at second use within 14 days after procedure |
| Change in Pain Visual Analog Score After Third Use of Device | Change in postoperative pain score after third use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. Participants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the third time they use the device. | baseline, 10 min, 2 hour, 4 hour at 3rd use within 14 days after procedure |
| Change in Pain Visual Analog Score After Fourth Use of Device |
| Measure | Description | Time Frame |
|---|---|---|
| Debridement Associated Pain Visual Analog Score Before Use of Device | Participants will record their pain before using the device at their postoperative debridement visits on post operative day 14 (POD14). Their pain levels will be recorded at baseline, 10 min, 2 hours, and 4 hours using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. | baseline, 10 min, 2 hour, 4 hour on POD14 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alfred-Marc Iloreta, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty Practice Associates - Mount Sinai Doctors | New York | New York | 10028 | United States |
No additional clinically relevant information will be collected from subjects in the course of the study beyond what is routinely collected and communicated to patients in their standard course of care. Study subjects will not be notified of results until the final analysis of study data is complete. The study results will be submitted for publication and/or presentation at national conferences/journals.
Not provided
Not provided
Not provided
Not provided
Not provided
60 patients met the inclusion criteria and enrolled into the study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Participants Screened | Participants consented and had screening visit to determine eligibility |
| FG001 | Microcurrent TENS Device | A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region Microcurrent TENS device: The study device is a handheld micro-current TENS emitter intended to be used for the relief of postoperative pain after FESS. The design of the study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated with the sinuses. |
| FG002 | Sham Device | The sham device appears identical to the active device while emitting no therapeutic microcurrent. Sham Device: The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screening Visit |
|
| ||||||||||||||||||
| Enrolled Participants |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Microcurrent TENS Device | A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region Microcurrent TENS device: The study device is a handheld micro-current TENS emitter intended to be used for the relief of postoperative pain after FESS. The design of the study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated with the sinuses. |
| 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 | Change in Pain Visual Analog Score After First Use of Device | Change in postoperative pain score in first use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. Participants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the first time they use the device. | Posted | Mean | Standard Deviation | score on a scale | baseline, 10 min, 2 hour, 4 hour at first use within 14 days after procedure |
|
21 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 | Microcurrent TENS Device | A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region Microcurrent TENS device: The study device is a handheld micro-current TENS emitter intended to be used for the relief of postoperative pain after FESS. The design of the study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated with the sinuses. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alfred Marc C Iloreta Jr, MD | Icahn School of Medicine at Mount Sinai | (212) 241-9410 | alfred-marc.iloreta@mountsinai.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 22, 2024 | Feb 12, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 9, 2023 | Feb 12, 2025 | ICF_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
Subjects will be randomly assigned in a 1:1 ratio to receive the intervention or placebo. Randomization will be completed via a computer-generated randomization table.
Not provided
Not provided
The participant and all study staff will be blinded to which device they are receiving, either the study device or the identical sham device. Devices will be labeled A or B, with only the device manufacturer knowing which device is the active study device and which is the sham.
|
|
| Sham Device | Device | The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic. |
|
Change in postoperative pain score after fourth use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. Participants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the fourth time they use the device. |
| baseline, 10 min, 2 hour, 4 hour at fourth use within 14 days after procedure |
| Change in Pain Visual Analog Score After Fifth Use of Device | Change in postoperative pain score after fifth use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. Participants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the fifth time they use the device. | baseline, 10 min, 2 hour, 4 hour at fifth use within 14 days after procedure |
| Sino-Nasal Outcome Test (SNOT 22) | The possible range of Total SNOT scores is between 0 to 110. Higher scores indicate greater rhinosinusitis-related health burden. | Baseline and 2 weeks Post-Op |
| Mean Difference in Nasal Obstruction Symptom Evaluation (NOSE) Score | Full scale from 0-100. Higher score indicates more severe symptoms | Baseline and 2 weeks Post-Op |
| Debridement Associated Pain Visual Analog Score After First Use of Device | Participants will record their pain before using the device at their postoperative debridement visits on post operative day 14 (POD14). Their pain levels will be recorded at baseline, 10 min, 2 hours, and 4 hours after the first use of device using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. | baseline, 10 min, 2 hour, 4 hour on POD14 |
| Debridement Associated Pain Visual Analog Score After Second Use of Device | Participants will record their pain before using the device at their postoperative debridement visits on post operative day 14 (POD14). Their pain levels will be recorded at baseline, 10 min, 2 hours, and 4 hours after the second use of device using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. | baseline, 10 min, 2 hour, 4 hour on POD14 |
| Debridement Associated Pain Visual Analog Score After Third Use of Device | Participants will record their pain before using the device at their postoperative debridement visits on post operative day 14 (POD14). Their pain levels will be recorded at baseline, 10 min, 2 hours, and 4 hours after the third use of device using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. | baseline, 10 min, 2 hour, 4 hour on POD14 |
| Debridement Associated Pain Visual Analog Score After Fourth Use of Device | Participants will record their pain before using the device at their postoperative debridement visits on post operative day 14 (POD14). Their pain levels will be recorded at baseline, 10 min, 2 hours, and 4 hours after the fourth use of device using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. | baseline, 10 min, 2 hour, 4 hour on POD14 |
| Postoperative Pain Medication Usage | Participants will record their postoperative pain medication daily usage (opioids and acetaminophen). Number of Acetaminophen 325mg or Number of Oxycodone 5 mg taken across 2 weeks post-op | Daily until 2nd postoperative visit (day 14) |
| NOT COMPLETED |
|
| BG001 | Sham Device | The sham device appears identical to the active device while emitting no therapeutic microcurrent. Sham Device: The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Prior Sinus Surgery | Count of Participants | Participants | No |
|
| Pre-Operative Diagnosis | Count of Participants | Participants | No |
|
| Septoplasty | Count of Participants | Participants |
|
| OG001 | Sham Device | The sham device appears identical to the active device while emitting no therapeutic microcurrent. Sham Device: The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic. |
|
|
| Primary | Change in Pain Visual Analog Score After Second Use of Device | Change in postoperative pain score after second use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. Participants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the second time they use the device. | Posted | Mean | Standard Deviation | score on a scale | baseline, 10 min, 2 hour, 4 hour at second use within 14 days after procedure |
|
|
|
| Primary | Change in Pain Visual Analog Score After Third Use of Device | Change in postoperative pain score after third use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. Participants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the third time they use the device. | Posted | Mean | Standard Deviation | score on a scale | baseline, 10 min, 2 hour, 4 hour at 3rd use within 14 days after procedure |
|
|
|
| Primary | Change in Pain Visual Analog Score After Fourth Use of Device | Change in postoperative pain score after fourth use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. Participants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the fourth time they use the device. | Posted | Mean | Standard Deviation | score on a scale | baseline, 10 min, 2 hour, 4 hour at fourth use within 14 days after procedure |
|
|
|
| Primary | Change in Pain Visual Analog Score After Fifth Use of Device | Change in postoperative pain score after fifth use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. Participants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the fifth time they use the device. | Posted | Mean | Standard Deviation | score on a scale | baseline, 10 min, 2 hour, 4 hour at fifth use within 14 days after procedure |
|
|
|
| Primary | Sino-Nasal Outcome Test (SNOT 22) | The possible range of Total SNOT scores is between 0 to 110. Higher scores indicate greater rhinosinusitis-related health burden. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 2 weeks Post-Op |
|
|
|
| Primary | Mean Difference in Nasal Obstruction Symptom Evaluation (NOSE) Score | Full scale from 0-100. Higher score indicates more severe symptoms | Posted | Mean | Standard Deviation | mean difference in score on a scale | Baseline and 2 weeks Post-Op |
|
|
|
| Secondary | Debridement Associated Pain Visual Analog Score Before Use of Device | Participants will record their pain before using the device at their postoperative debridement visits on post operative day 14 (POD14). Their pain levels will be recorded at baseline, 10 min, 2 hours, and 4 hours using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. | Posted | Mean | Standard Deviation | score on a scale | baseline, 10 min, 2 hour, 4 hour on POD14 |
|
|
|
| Secondary | Debridement Associated Pain Visual Analog Score After First Use of Device | Participants will record their pain before using the device at their postoperative debridement visits on post operative day 14 (POD14). Their pain levels will be recorded at baseline, 10 min, 2 hours, and 4 hours after the first use of device using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. | Posted | Mean | Standard Deviation | score on a scale | baseline, 10 min, 2 hour, 4 hour on POD14 |
|
|
|
| Secondary | Debridement Associated Pain Visual Analog Score After Second Use of Device | Participants will record their pain before using the device at their postoperative debridement visits on post operative day 14 (POD14). Their pain levels will be recorded at baseline, 10 min, 2 hours, and 4 hours after the second use of device using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. | Posted | Mean | Standard Deviation | score on a scale | baseline, 10 min, 2 hour, 4 hour on POD14 |
|
|
|
| Secondary | Debridement Associated Pain Visual Analog Score After Third Use of Device | Participants will record their pain before using the device at their postoperative debridement visits on post operative day 14 (POD14). Their pain levels will be recorded at baseline, 10 min, 2 hours, and 4 hours after the third use of device using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. | Posted | Mean | Standard Deviation | score on a scale | baseline, 10 min, 2 hour, 4 hour on POD14 |
|
|
|
| Secondary | Debridement Associated Pain Visual Analog Score After Fourth Use of Device | Participants will record their pain before using the device at their postoperative debridement visits on post operative day 14 (POD14). Their pain levels will be recorded at baseline, 10 min, 2 hours, and 4 hours after the fourth use of device using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. | Posted | Mean | Standard Deviation | score on a scale | baseline, 10 min, 2 hour, 4 hour on POD14 |
|
|
|
| Secondary | Postoperative Pain Medication Usage | Participants will record their postoperative pain medication daily usage (opioids and acetaminophen). Number of Acetaminophen 325mg or Number of Oxycodone 5 mg taken across 2 weeks post-op | Posted | Mean | Standard Deviation | number of pills | Daily until 2nd postoperative visit (day 14) |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Sham Device | The sham device appears identical to the active device while emitting no therapeutic microcurrent. Sham Device: The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic. | 0 | 33 | 0 | 33 | 0 | 33 |
Not provided
Not provided
Not provided
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| 2 hour |
|
| 4 hour |
|
| 2 hour |
|
| 4 hour |
|
| 2 hour |
|
| 4 hour |
|
| 2 hour |
|
| 4 hour |
|
| 2 hour |
|
| 4 hour |
|
| 2 hour |
|
| 4 hour |
|
| 2 hour |
|
| 4 hour |
|
| 2 hour |
|
| 4 hour |
|
| 2 hour |
|
| 4 hour |
|