Clinical trial NCT02584088: Ultrasound Appearance of the Endometrium Post Radio-Frequency Ablation
Official title: Ultrasound Appearance of the Endometrium Post Radio-Frequency Ablation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menorrhagia
Keywords: NovaSure
Ablation
Menorrhagia
Endometrium
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2015-10-22
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are candidates for NovaSure ablation for treatment of menorrhagia.

Brief summary: * The study primarily aims to evaluate the post ablative endometrium and uterus using transvaginal ultrasound to provide descriptive information as to what may be expected in the 12 months after a NovaSure ablation. Investigators believe this knowledge will help them to determine when to proceed with further evaluation postoperatively or when to counsel patients on expectant management based on ultrasonographic findings.
* Secondary aims include correlation of ultrasonographic findings to demographic patient data.

Detailed description: Heavy and irregular menses affects 9-14% of gynecologic patients. Surgical can be employed intervention is sought when medical management fails. Endometrial ablation or desiccation of the endometrium using minimally invasive instruments has been utilized in this scenario. The current mainstay intervention is non-resectoscopic radio frequency ablation. These procedures have high satisfaction rates (81 to 93%) similar to hysterectomy and leave up to 47% of patients amenorrheic. Post operative complications, both short and long term, and failure rates have been well studied. A limited number of studies have been performed to assess the histologic state of the post ablative endometrium and fewer assessing the radiographic appearance of the endometrium. Therefore, this current study aims to describe the ultrasonographic appearance of the post ablative endometrium and uterus.

Eligibility criteria: Inclusion Criteria:

* women of premenopausal age
* 18 years and older
* intended ablative management of menorrhagia

Exclusion Criteria:

* uterine cavity anatomic abnormality
* previous uterine ablation procedure
* previous cervical procedure
* presence of submucosal fibroids
* tissue diagnosis of endometrial hyperplasia/endometrial carcinoma
* pregnancy and delivery less than 1 year before ablation.

Primary outcomes:
measure: Endometrial thickness (measured using a scale)
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Bethesda North Hospital
state: Ohio
Study officials:
affiliation: TriHealth Inc.
name: Catrina Crisp, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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