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Ultrasound Appearance of the Endometrium Post Radio-Frequency Ablation

Ultrasound Appearance of the Endometrium Post Radio-Frequency Ablation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02584088
Enrollment
80
Registered
2015-10-22
Start date
2016-10-11
Completion date
2021-11-30
Last updated
2022-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menorrhagia

Keywords

NovaSure, Ablation, Menorrhagia, Endometrium

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.

Interventions

OTHERUltrasound

The appearance of the post ablative endometrium on transvaginal ultrasound at 2, 6, and 12 months.

Sponsors

TriHealth Inc.
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Endometrial thickness (measured using a scale)2 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026