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Completed

NCT Number: NCT02584088

Ultrasound Appearance of the Endometrium Post Radio-Frequency Ablation

* 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.

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Key information

Conditions

Menorrhagia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Bethesda North Hospital, Cincinnati, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ultrasound

Other

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

Primary outcomes

  1. Endometrial thickness (measured using a scale)

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Oct 22, 2015
Registry last updated
Dec 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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