Adenomyosis
Conditions
Keywords
adenomyosis, radiofrequency ablation
Brief summary
To observe the effects of radiofrequency ablation on adenomyosis through the pathological analysis of treated tissue that has been removed during planned hysterectomy.
Detailed description
The ProVu™ System (Hologic, Inc., Boston, MA) is designed and cleared by the FDA as a treatment method for soft tissue, including the treatment of symptomatic uterine fibroids. After locating the general region of the target tissue, a laparoscopic ultrasound transducer is placed on the serosal surface of the uterus to identify the size, location, and number of focal adenomyosis (or adenomyomas). Under ultrasound guidance, the treatment probe (handpiece) is inserted through the serosal surface and into the target tissue. The electrode array containing multiple thermocouples is then deployed according to the size of the target tissue and the position is verified using the ultrasound transducer. Once correctly placed, the surgeon initiates ablation by pressing the foot pedal. Continuous temperature feedback is displayed on the generator screen. For safety purposes, dispersive pads are placed on the patient's thighs to disperse electrical current. If the target tissue is irregular or large, the needle array is retracted and the probe repositioned within the same area under ultrasound guidance. The ablation is repeated until the area of interest is ablated. Overlapping ablations may be required. At the conclusion of the final ablation, the surgeon retracts the array withdraws the probe through the serosal surface of the uterus while coagulating the track to avoid bleeding. Once hemostasis is confirmed and all target tissue has been treated, the surgeon proceeds with the planned hysterectomy and the tissue is examined by a pathologist to assess the ablation zones within the adenomyoma or focal adenomyosis.
Interventions
DEVICERF Treatment
ProVu treatment probe will be energized and RF energy delivered in a pre-programmed, controlled method based on the predetermined size of the affected tissue.
Sponsors
University of Texas Southwestern Medical Center
Hologic, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* planning to undergo an abdominal, laparoscopic, or robotic-assisted hysterectomy due to benign conditions * uterus \< 16 weeks gestational size if undergoing a laparoscopic or robotic procedure (no size limit for patients planning to undergo a transabdominal hysterectomy) * at least one area of focal or diffuse adenomyosis or adenomyomas that is/are contralateral to any fibroids as determined by MRI * able to provide informed consent * suitable candidates for surgery (have passed a standard pre-operative health assessment) * English speaking
Exclusion criteria
* require emergent hysterectomy or vaginal hysterectomy * have a uterus \> 16 weeks gestational size if undergoing a laparoscopic or robotic procedure (no size limit for patients planning to undergo a transabdominal hysterectomy) * have fibroids in the proximity of the target adenomyosis (same side, similar location) * are not appropriate surgical candidates as determined during pre-operative health assessment * are unable or unwilling to undergo a hysterectomy * are pregnant or lactating * are under the age of 18 years * have active pelvic inflammatory disease * have a history of gynecologic malignancy within the past 3 years * are unable to give informed consent * have an implantable uterine or fallopian tube device for contraception * are not English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Evidence of Adenomyoma Tissue Ablation Effect by Area (n) as Assessed by Pathological Analysis | Post-intervention (i.e., within 4 hours of RF (radiofrequency) treatment and 2 hours of completion of hysterectomy) | Participants who provided at least one post-ablation tissue area for histological evaluation are included in the analysis population. The unit of analysis for this outcome is the individual tissue area (specimen/region). Each area is examined by a pathologist and assigned to one of categories: Treated areas with no adenomyois noted; Treated areas with definitive thermal artifact on serosa; Treated areas with documented thermal artifact on endometrium; Dilated, prominent more thick-walled / small ectatic vessels with thermal artifact on or around them; and Treated areas with adenomyosis identified microscopically. Counts in the results table are based on the total number of evaluated areas within each group. |
Countries
United States
Contacts
STUDY_DIRECTORKimberly Kho, MD
Hawaii Pacific Health
Participant flow
Recruitment details
Participants recruited in gynecology clinic who were planning to undergo hysterectomy for MRI confirmed adenomyosis over 30 months.
Pre-assignment details
1 patient withdrew consent prior to the hysterectomy
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 40.9 years STANDARD_DEVIATION 7.6 |
| BMI | 27.6 kg/m^2 STANDARD_DEVIATION 6.3 |
| Gravity | 2 pregnancies STANDARD_DEVIATION 2.8 |
| Race/Ethnicity, Customized African-American | 1 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Hispanic | 2 Participants |
| Race/Ethnicity, Customized Other/Unknown | 4 Participants |
| Race/Ethnicity, Customized White | 6 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
None listed