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Neoplasms, Fibrous Tissue

VizAblate System with subject serving as her own control

The VizAblate System is indicated for use in transcervical intrauterine-guided radio frequency ablation of uterine fibroids

VizAblate System

David Toub, MD

Study is intended to evaluate the one-year safety and clinical status of patients treated for symptomatic uterine fibroids with the VizAblate Intrauterine-ultrasound guided radio frequency (RF) ablation system. Particular attention will be directed to recording safety outcomes including incidence of uterine cavity synechiae. In addition, information on quality of life will be collected.

Overall study duration (first patient enrolled through last patient exit) will be comprised of approximately 12 months of patient enrollment up to 1 month for scheduling of treatment, and 12 months of follow-up, for a total duration of up to 25 months. Study duration for an individual patient, once enrolled, will be approximately 1 month for baseline observations and treatment scheduling, and 12 months for follow up after treatment for a total duration of approximately 13 months.

In this single-arm study, subjects who receive transcervical intrauterine-ultrasound guided RF ablation of symptomatic uterine fibroids with the VizAblate® System will be assessed with 3D pelvic sonography with contrast, hysteroscopy, and quality of life questionnaires.

Overall study duration (first patient enrolled through last patient exit) will be comprised of approximately 12 months of patient enrollment up to 1 month for scheduling of treatment, and 12 months of follow-up, for a total duration of up to 25 months. Study duration for an individual patient, once enrolled, will be approximately 1 month for baseline observations and treatment scheduling, and 12 months for follow up after treatment for a total duration of approximately 13 months.

Observational Prospective Study on Patients With Symptomatic Uterine Fibroids Treated With VizAblate® Intrauterine-ultrasound Guided RF Ablation

The cavity will be as classified per the European Society for Hysteroscopy (ESH)

Frequency and type of adverse events occurring on the day of the procedure

Frequency and type of adverse events occurring post treatment through 12 months

Gynesonics

Rare Diseases

Sarcoma

Soft Tissue Sarcoma

Uterine Sarcoma

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Echo-guided uterine biopsy will be performed by a specialized radiologist by transvaginal and exclusive transuterine approach. 4 to 5 samples will be made.

Local anesthesia will be performed. A pain assessment will be performed during the biopsy (visual or verbal scale).

Echo-guided uterine biopsy

Frédéric GUYON, MD

Simone MATHOULIN-PELISSIER, MD, PhD

Denis QUERLEU, MD, PhD

This is a prospective multi-center interventional study that will be performed in an effort to assess the diagnostic accuracy performance of preoperative vaginal ultrasound-guided biopsy (VUGB) to detect the exact histology of uterine tumors and thereafter triage cases being eligible for morcellation during laparoscopic resection. Ten tertiary French centers will participate in the present study.

Prior to carrying out the research, the informed consent of the person must be obtained after being informed of the purpose of the research, its conduct and duration, benefits, potential risks and constraints of the study.

During the inclusion check-up, exams must be performed within 30 days before the guided echo biopsy: clinical examination, gynecological examination, pain assessment (visual or verbal scale), biological and radiological assessment (Doppler ultrasound Pelvis and MRI pelvis).

The echo-guided biopsy will be performed by a specialized radiologist by transvaginal and exclusive transuterine approach. Local anesthesia will be performed. A pain assessment will be performed during the biopsy (visual or verbal scale).

Between the biopsy and the procedure, the patient will be reviewed by the investigating surgeon to check the outcome of the biopsy, any pain or complications of the biopsy.

The surgical procedure will be performed by laparotomy and will consist of an extra-facial hysterectomy without fragmentation of the surgical specimen (extraction technique "in block"). During the procedure, the investigating surgeon will perform a description of the abdominal and pelvic cavity and perform a block excision of the tumor.

At one month of the surgery, patient will be reviewed by the investigating surgeon for a postoperative visit with clinical examination, gynecological and histopathological results.

Thereafter, the follow-up of the patients will be carried out according to the standards of care according to the histopathological results.

Diagnostic Performances of Preoperative Echo-guided Uterine Biopsy in the Management of Suspect Uterine Sarcoma Tumors (BIOPSAR)

Diagnostic Performances of Preoperative Echo-guided Uterine Biopsy in the Management of Suspect Uterine Sarcoma Tumors

Sensitivity is the proportion of patients with malignant/STUMP result on the local reading of biopsy (index test) divided by the number of patients with malignant/STUMP result on the local reading of surgical specimen (reference standard). Primary outcome assessment will be based on the local reading.

Specificity is the proportion of patients with benign result on the local reading of biopsy divided by the number of patients with benign result on the local reading of surgical specimen.

Accuracy is the proportion of patients with true results: true positives (TP) + true negatives (TN) divided by number of cases. Accuracy ranges from 0 (100% false positives and false negatives) to 1 (100% true positives and true negatives). Assessment will be based on the local reading.

Youden's index is defined as sensitivity+specificity-1. The maximum value of the Youden index is 1 (perfect test) and the minimum is 0 when the test has no diagnostic value. Assessment will be based on the local reading.

PPV is the proportion of patients with malignant/STUMP results on the local reading of biopsy and surgical specimen (true positives) divided by the number of patients who might or might not have malignant/STUMP results (True positives+False positives).

NPV is the proportion of patients with benign results on the local reading of biopsy and surgical specimen (true negatives) divided by the number of patients who might or might not have benign results (True negatives+ False negatives)

Sensitivity is the proportion of patients with malignant/STUMP result on the centralized review of biopsy (index test) divided by the number of patients with malignant/STUMP result on the centralized review of surgical specimen (reference standard).

Specificity is the proportion of patients with benign result on the centralized review of biopsy divided by the number of patients with benign result on the centralized review of surgical specimen.

Accuracy is the proportion of patients with true results: true positives (TP) + true negatives (TN) divided by number of cases. Accuracy ranges from 0 (100% false positives and false negatives) to 1 (100% true positives and true negatives). Assessment will be based on the centralized review by an expert pathologist.

Youden's index is defined as sensitivity+specificity-1. The maximum value of the Youden index is 1 (perfect test) and the minimum is 0 when the test has no diagnostic value. Assessment will be based on the centralized review by an expert pathologist.

PPV is the proportion of patients with malignant/STUMP results on the centralized review of biopsy and surgical specimen (true positives) divided by the number of patients who might or might not have malignant/STUMP results (True positives+False positives).

NPV is the proportion of patients with benign results on centralized review of biopsy and surgical specimen (true negatives) divided by the number of patients who might or might not have benign results (True negatives+ False negatives).

Sensitivity is the proportion of patients with malignant/STUMP result on imaging divided by the number of patients with malignant/STUMP result on the local reading of surgical specimen (reference standard).

Specificity is the proportion of patients with benign result on imaging divided by the number of patients with benign result on the local reading of surgical specimen.

Accuracy is the proportion of patients with true results: true positives (TP) + true negatives (TN) divided by number of cases. Accuracy ranges from 0 (100% false positives and false negatives) to 1 (100% true positives and true negatives).

Youden's index is defined as sensitivity+specificity-1. The maximum value of the Youden index is 1 (perfect test) and the minimum is 0 when the test has no diagnostic value.

PPV is the proportion of patients with malignant/STUMP results on imaging and surgical specimen (true positives) divided by the number of patients who might or might not have malignant/STUMP results (True positives+False positives).

NPV is the proportion of patients with benign results on Imaging and surgical specimen (true negatives) divided by the number of patients who might or might not have benign results (True negatives+ False negatives)

Cohen's Kappa coefficient. kappa coefficient values greater than 0.75 correspond to acceptable reproducibility.

The minimum value is 0 and the maximum value is 10. A high score of pain indicates a high level of pain.

Complications related to biopsy will be evaluated after biopsy.

Adverse events will be evaluated at inclusion, on the day of the biopsy and after the biopsy.

PFS is defined as the time interval between the date of surgery and the date of progression and/or death whichever occurs first

OS is defined as the time interval between the date of surgery and the date of death (of any cause).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Observational Prospective Study on Patients With Symptomatic Uterine Fibroids Treated With VizAblate® Intrauterine-ultrasound Guided RF Ablation	NCT01998854	Menorrhagia Leiomyoma Uterine Fibroid... Uterine Fibroma Uterine Neoplas...	VizAblate Syste...	28 Years -	Gynesonics
Diagnostic Performances of Preoperative Echo-guided Uterine Biopsy in the Management of Suspect Uterine Sarcoma Tumors (BIOPSAR)	NCT04250766	Fibroid Uterus Sarcoma Uterus	Echo-guided ute...	35 Years -	Institut Bergonié
Diagnostic Performances of Preoperative Echo-guided Uterine Biopsy in the Management of Suspect Uterine Sarcoma Tumors (BIOPSAR)	NCT04250766	Fibroid Uterus Sarcoma Uterus	Echo-guided ute...	35 Years -	Institut Bergonié

Spots Global Cancer Trial Database for uterine fibroma