BridgeMD
New treatment option for Thyroid Carcinoma
Official title Nanosecond Pulsed Field Ablation in the Management of T1N0M0 Papillary Thyroid Carcinoma
ClinicalTrials.gov ID: NCT07218315
What this study is testing
- What it's testing
- This study is to evaluate the effectiveness of nsPFA in treating papillary thyroid microcarcinoma. T
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant must provide voluntary, written informed consent to participate in this clinical investigation.
- Participant agrees to comply with all study procedures, including all follow-up visits.
- Participant with a Bethesda VI cytology (tumor size \<= 1.5 cm, no known regional/distant metastases)
- Participant with a Bethesda V cytology and normal calcitonin levels.
- Ultrasonographic evaluation of tumor to be ablated must show size of less than or equal to 1.5 cm and no extrathyroidal extension or locoregional...
You likely can't join if
- FNA findings suggestive of high-grade malignancy
- Presence of regional or distant lymph node metastases.
- Participant had a history of previous neck irradiation.
- Females who are pregnant at time of enrollment.
- Participant has any condition or situation, in the opinion of the site Investigator, that puts the subject at significant risk, could confound the...
See the full eligibility criteria
- Participant must provide voluntary, written informed consent to participate in this clinical investigation.
- Participant agrees to comply with all study procedures, including all follow-up visits.
- Participant with a Bethesda VI cytology (tumor size \<= 1.5 cm, no known regional/distant metastases)
- Participant with a Bethesda V cytology and normal calcitonin levels.
- Ultrasonographic evaluation of tumor to be ablated must show size of less than or equal to 1.5 cm and no extrathyroidal extension or locoregional metastases.
- Participant must have normal complete blood count, blood coagulation profile, and thyroid function test.
- For females of childbearing potential, a negative serum or urine pregnancy test must be obtained at baseline, prior to the procedure.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to...
- Postmenopausal (no menses in greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure.
- Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy...
- Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study procedure.
- FNA findings suggestive of high-grade malignancy
- Presence of regional or distant lymph node metastases.
- Participant had a history of previous neck irradiation.
- Females who are pregnant at time of enrollment.
- Participant has any condition or situation, in the opinion of the site Investigator, that puts the subject at significant risk, could confound the study results, or may interfere significantly with subject's...
The study team makes the final eligibility decision.
Where it's taking place
- Sarasota, Florida, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sarasota, Florida, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.