Trial Outcomes & Findings for Effect of Ultrasound Guided Laser Ablation Therapy on Symptomatic Benign Thyroid Nodules (NCT NCT04277455)
NCT ID: NCT04277455
Last Updated: 2024-06-03
Results Overview
Percentage change from baseline volume will be calculated at 3, 6 and 12 months after laser treatment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
12 months
Results posted on
2024-06-03
Participant Flow
Participant milestones
| Measure |
Treatment Arm
Patients will receive laser treatment for benign symptomatic nodules
Laser ablation of benign thyroid nodule: Ablating symptomatic benign thyroid nodules using laser
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment Arm
Patients will receive laser treatment for benign symptomatic nodules
Laser ablation of benign thyroid nodule: Ablating symptomatic benign thyroid nodules using laser
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment Arm
n=10 Participants
Patients will receive laser treatment for benign symptomatic nodules
Laser ablation of benign thyroid nodule: Ablating symptomatic benign thyroid nodules using laser
|
|---|---|
|
Age, Continuous
|
56 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
|
Baseline volume of the index thyroid nodule
|
17.43 mm^3
n=10 Participants
|
|
Baseline visual inspection of the neck at 1 m
Presented with visible nodule at a distance of > 1 meter
|
10 participants
n=10 Participants
|
|
Baseline visual inspection of the neck at 1 m
Presented with no visible nodule at a distance of > 1 meter
|
0 participants
n=10 Participants
|
|
Baseline symptoms
Reported neck pain
|
1 participants
n=10 Participants
|
|
Baseline symptoms
Reported neck tenderness
|
6 participants
n=10 Participants
|
|
Baseline symptoms
Reported neck tightness
|
9 participants
n=10 Participants
|
|
Baseline symptoms
Reported difficulty swallowing
|
7 participants
n=10 Participants
|
|
Baseline symptoms
Reported voice changes
|
2 participants
n=10 Participants
|
|
Baseline symptoms
Reported shortness of breath
|
2 participants
n=10 Participants
|
|
Baseline symptoms
Reported cosmetic disfigurement
|
5 participants
n=10 Participants
|
|
Baseline TSH
|
1.22 µU/mL
n=10 Participants
|
|
Baseline Free T4
|
1.26 ng/dL
n=10 Participants
|
|
Baseline Free T3
|
3.12 pmol/L
n=10 Participants
|
|
Baseline antithyroid antibodies
TPO Antibodies
|
6.8 IU/mL
n=10 Participants
|
|
Baseline antithyroid antibodies
Thyroglobulin Antibodies
|
11 IU/mL
n=10 Participants
|
|
Baseline status of vocal fold structure and function
Presented as normal
|
10 Participants
n=10 Participants
|
|
Baseline status of vocal fold structure and function
Presented as abnormal
|
0 Participants
n=10 Participants
|
|
Baseline pain score
Pain score of 0
|
6 participants
n=10 Participants
|
|
Baseline pain score
Pain score of 1
|
2 participants
n=10 Participants
|
|
Baseline pain score
Pain score of 4
|
2 participants
n=10 Participants
|
|
Cosmetic assessment at baseline
|
2.7 score on a scale
n=10 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 9 subjects completed the 12-month post-procedure study visit. One patient did not return for the 12-month follow up visit and was determined to be lost to follow-up.
Percentage change from baseline volume will be calculated at 3, 6 and 12 months after laser treatment.
Outcome measures
| Measure |
Treatment Arm
n=10 Participants
Patients will receive laser treatment for benign symptomatic nodules
Laser ablation of benign thyroid nodule: Ablating symptomatic benign thyroid nodules using laser
|
|---|---|
|
Change in Radiographic Volume of Thyroid Nodule From Baseline at 3, 6 and 12 Months After Laser Ablation
Average change in volume of thyroid nodule at the 3-months post-procedure study visit
|
63.4 percentage of volume reduction
Interval 26.3 to 75.5
|
|
Change in Radiographic Volume of Thyroid Nodule From Baseline at 3, 6 and 12 Months After Laser Ablation
Average change in volume of thyroid nodule from baseline to 12-months
|
71.087 percentage of volume reduction
Interval 30.95 to 91.062
|
PRIMARY outcome
Timeframe: 12 monthsNumber of patients who develops hypo or hyperthyroidism 3,6 and 12 months after laser treatment.
Outcome measures
| Measure |
Treatment Arm
n=10 Participants
Patients will receive laser treatment for benign symptomatic nodules
Laser ablation of benign thyroid nodule: Ablating symptomatic benign thyroid nodules using laser
|
|---|---|
|
Change in the Thyroid Function After Laser Treatment Assessed by the Measurement of TSH and Free T4 at 3, 6 and 12 Months After Laser Ablation
Demonstrated a clinically significant change
|
0 participants
|
|
Change in the Thyroid Function After Laser Treatment Assessed by the Measurement of TSH and Free T4 at 3, 6 and 12 Months After Laser Ablation
Did not demonstrate a clinically significant change
|
10 participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 9 subjects completed the 12-month post-procedure study visit. One patient did not return for the 12-month follow up visit and was determined to be lost to follow-up.
Number of patients who had changes in blood flow inside the thyroid nodule as evidenced by change in Doppler grade.
Outcome measures
| Measure |
Treatment Arm
n=10 Participants
Patients will receive laser treatment for benign symptomatic nodules
Laser ablation of benign thyroid nodule: Ablating symptomatic benign thyroid nodules using laser
|
|---|---|
|
Change in Doppler Grade at 3, 6, and 12 Months After Laser Ablation
3 months
|
1 Participants
|
|
Change in Doppler Grade at 3, 6, and 12 Months After Laser Ablation
6 months
|
0 Participants
|
|
Change in Doppler Grade at 3, 6, and 12 Months After Laser Ablation
12 months
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 monthsNumber of patients who develops new thyroid antibodies 3,6, and 12 months after laser ablation
Outcome measures
| Measure |
Treatment Arm
n=10 Participants
Patients will receive laser treatment for benign symptomatic nodules
Laser ablation of benign thyroid nodule: Ablating symptomatic benign thyroid nodules using laser
|
|---|---|
|
Change in Thyroid Antibody Levels 3,6 and 12 Months After Laser Ablation
Demonstrated a clinically significant change
|
0 participants
|
|
Change in Thyroid Antibody Levels 3,6 and 12 Months After Laser Ablation
Did not demonstrate a clinically significant change
|
10 participants
|
PRIMARY outcome
Timeframe: 3 months, 6 months, and 12 months after procedurePopulation: 9 subjects completed the 12-month post-procedure study visit. One patient did not return for the 12-month follow up visit and was determined to be lost to follow-up.
Patients perceived cosmetic appearance will be measured using a numerical scale at baseline, immediately after procedure and then at 3, 6 and 12 months after procedure using following question. On a scale from 0 to 10, how much does your thyroid nodule affect your appearance? 0 being the best outcome and 10 being the worst outcome.
Outcome measures
| Measure |
Treatment Arm
n=10 Participants
Patients will receive laser treatment for benign symptomatic nodules
Laser ablation of benign thyroid nodule: Ablating symptomatic benign thyroid nodules using laser
|
|---|---|
|
Cosmetic Assessment at 3,6 and 12 Months and Immediately After Laser Ablation Measured Using a Numerical Scale
Reported Immediately after procedure
|
3 score on a scale
Interval 0.0 to 7.0
|
|
Cosmetic Assessment at 3,6 and 12 Months and Immediately After Laser Ablation Measured Using a Numerical Scale
3 months
|
0.9 score on a scale
Interval 0.0 to 3.0
|
|
Cosmetic Assessment at 3,6 and 12 Months and Immediately After Laser Ablation Measured Using a Numerical Scale
6 months
|
0.6 score on a scale
Interval 0.0 to 3.0
|
|
Cosmetic Assessment at 3,6 and 12 Months and Immediately After Laser Ablation Measured Using a Numerical Scale
12 months
|
.78 score on a scale
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: Immediately post-procedureChange in pain will be measured using a numerical scale at baseline, immediately post procedure and 3 months after procedure using the following question. Rate your pain on a scale from 0 to 10 where 0 is no pain and 10 is the worst pain possible.
Outcome measures
| Measure |
Treatment Arm
n=9 Participants
Patients will receive laser treatment for benign symptomatic nodules
Laser ablation of benign thyroid nodule: Ablating symptomatic benign thyroid nodules using laser
|
|---|---|
|
Reported Pain Score on the Numerical Scale Immediately Post Procedure.
|
5.5 pain score on a scale
Interval 2.0 to 9.0
|
SECONDARY outcome
Timeframe: Post-procedure on the day of procedureParticipants will be asked to answer the following questionnaire after the procedure. How likely is it that you would have the laser ablation procedure again? 1 = Very Likely 2 = Somewhat Likely 3 = Not Likely
Outcome measures
| Measure |
Treatment Arm
n=10 Participants
Patients will receive laser treatment for benign symptomatic nodules
Laser ablation of benign thyroid nodule: Ablating symptomatic benign thyroid nodules using laser
|
|---|---|
|
Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure.
1 = Very Likely
|
7 Participants
|
|
Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure.
2 = Somewhat Likely
|
3 Participants
|
|
Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure.
3 = Not Likely
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 yearTreatment related adverse events will be captured using CTCAE v4,0 format
Outcome measures
| Measure |
Treatment Arm
n=10 Participants
Patients will receive laser treatment for benign symptomatic nodules
Laser ablation of benign thyroid nodule: Ablating symptomatic benign thyroid nodules using laser
|
|---|---|
|
Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0
Sensation of lump in throat
|
1 Participants
|
|
Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0
Burning sensation in neck at needle stick site
|
1 Participants
|
|
Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0
Sore throat
|
1 Participants
|
|
Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0
Feeling of a knot in neck at needle stick site
|
1 Participants
|
|
Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0
Coughing
|
1 Participants
|
|
Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0
Bruising to neck
|
2 Participants
|
|
Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0
Pain/discomfort with swallowing
|
2 Participants
|
|
Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0
Difficulty swallowing
|
1 Participants
|
|
Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0
Swelling at needle stick site
|
6 Participants
|
|
Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0
Pain/soreness in neck
|
10 Participants
|
SECONDARY outcome
Timeframe: 3 monthsChange in pain will be measured using a numerical scale at baseline, immediately post procedure and 3 months after procedure using the following question. Rate your pain on a scale from 0 to 10 where 0 is no pain and 10 is the worst pain possible.
Outcome measures
| Measure |
Treatment Arm
n=10 Participants
Patients will receive laser treatment for benign symptomatic nodules
Laser ablation of benign thyroid nodule: Ablating symptomatic benign thyroid nodules using laser
|
|---|---|
|
Reported Pain Score on the Numerical Scale 3 Months Post Procedure.
Pain score greater than 0
|
0 participants
|
|
Reported Pain Score on the Numerical Scale 3 Months Post Procedure.
Pain score of 0
|
10 participants
|
SECONDARY outcome
Timeframe: Post-procedure on day of procedureParticipants will be asked to answer the following questionnaire after the procedure. How satisfied were you with the length of the laser ablation procedure? 1= Satisfied 2 = Neither 3 = Dissatisfied
Outcome measures
| Measure |
Treatment Arm
n=10 Participants
Patients will receive laser treatment for benign symptomatic nodules
Laser ablation of benign thyroid nodule: Ablating symptomatic benign thyroid nodules using laser
|
|---|---|
|
Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure.
1= Satisfied
|
7 Participants
|
|
Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure.
2 = Neither
|
2 Participants
|
|
Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure.
3 = Dissatisfied
|
1 Participants
|
SECONDARY outcome
Timeframe: Post-procedure on day of procedureParticipants will be asked to answer the following questionnaire after the procedure. How much discomfort did you have with the laser ablation procedure? 1= Less than I thought 2 = About what I thought 3 = More than I thought
Outcome measures
| Measure |
Treatment Arm
n=10 Participants
Patients will receive laser treatment for benign symptomatic nodules
Laser ablation of benign thyroid nodule: Ablating symptomatic benign thyroid nodules using laser
|
|---|---|
|
Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure.
1= Less than I thought
|
1 Participants
|
|
Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure.
2 = About what I thought
|
3 Participants
|
|
Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure.
3 = More than I thought
|
6 Participants
|
Adverse Events
Treatment Arm
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Arm
n=10 participants at risk
Patients will receive laser treatment for benign symptomatic nodules
Laser ablation of benign thyroid nodule: Ablating symptomatic benign thyroid nodules using laser
|
|---|---|
|
Skin and subcutaneous tissue disorders
Feeling of a knot in neck at needle stick site
|
10.0%
1/10 • Adverse events were monitored throughout the study, an average of 12 months.
|
|
Musculoskeletal and connective tissue disorders
Sensation of lump in throat
|
10.0%
1/10 • Adverse events were monitored throughout the study, an average of 12 months.
|
|
Skin and subcutaneous tissue disorders
Burning sensation in neck at needle stick site
|
10.0%
1/10 • Adverse events were monitored throughout the study, an average of 12 months.
|
|
Musculoskeletal and connective tissue disorders
Sore throat
|
10.0%
1/10 • Adverse events were monitored throughout the study, an average of 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
10.0%
1/10 • Adverse events were monitored throughout the study, an average of 12 months.
|
|
Skin and subcutaneous tissue disorders
Bruising to neck
|
20.0%
2/10 • Adverse events were monitored throughout the study, an average of 12 months.
|
|
Musculoskeletal and connective tissue disorders
Pain/discomfort with swallowing
|
20.0%
2/10 • Adverse events were monitored throughout the study, an average of 12 months.
|
|
Musculoskeletal and connective tissue disorders
Difficulty swallowing
|
10.0%
1/10 • Adverse events were monitored throughout the study, an average of 12 months.
|
|
Skin and subcutaneous tissue disorders
Swelling at needle stick site
|
60.0%
6/10 • Adverse events were monitored throughout the study, an average of 12 months.
|
|
Musculoskeletal and connective tissue disorders
Pain/soreness in neck
|
100.0%
10/10 • Adverse events were monitored throughout the study, an average of 12 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place