Ultrasound Appearance of the Endometrium Post Radio-Frequency Ablation

NCT02584088 | Completed

• 1 other identifier: 15-029
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Menorrhagia

Keywords

NovaSure; Ablation; Menorrhagia; Endometrium

Outcome Measures

Primary Outcomes (1)

• Endometrial thickness (measured using a scale)

  2 months

Interventions

Ultrasound OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are candidates for NovaSure ablation for treatment of menorrhagia.

You may qualify if:

• women of premenopausal age
• years and older
• intended ablative management of menorrhagia

You may not qualify if:

• 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.

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (2)

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

Bethesda North Hospital

Cincinnati, Ohio, 45242, United States

Location

Related Publications (10)

• El-Nashar SA, Hopkins MR, Creedon DJ, St Sauver JL, Weaver AL, McGree ME, Cliby WA, Famuyide AO. Prediction of treatment outcomes after global endometrial ablation. Obstet Gynecol. 2009 Jan;113(1):97-106. doi: 10.1097/AOG.0b013e31818f5a8d.

  PMID: 19104365 BACKGROUND

• Dickersin K, Munro MG, Clark M, Langenberg P, Scherer R, Frick K, Zhu Q, Hallock L, Nichols J, Yalcinkaya TM; Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding (STOP-DUB) Research Group. Hysterectomy compared with endometrial ablation for dysfunctional uterine bleeding: a randomized controlled trial. Obstet Gynecol. 2007 Dec;110(6):1279-89. doi: 10.1097/01.AOG.0000292083.97478.38.

  PMID: 18055721 BACKGROUND

• Alhilli MM, Wall DJ, Brown DL, Weaver AL, Hopkins MR, Famuyide AO. Uterine ultrasound findings after radiofrequency endometrial ablation: correlation with symptoms. Ultrasound Q. 2012 Dec;28(4):261-8. doi: 10.1097/RUQ.0b013e318276653b.

  PMID: 23149510 BACKGROUND

• Ahonkallio SJ, Liakka AK, Martikainen HK, Santala MJ. Feasibility of endometrial assessment after thermal ablation. Eur J Obstet Gynecol Reprod Biol. 2009 Nov;147(1):69-71. doi: 10.1016/j.ejogrb.2009.06.014. Epub 2009 Jul 16.

  PMID: 19615812 BACKGROUND

• Penninx JPM, Herman MC, Mol BW, Bongers MY. Five-year follow-up after comparing bipolar endometrial ablation with hydrothermablation for menorrhagia. Obstet Gynecol. 2011 Dec;118(6):1287-1292. doi: 10.1097/AOG.0b013e318236f7ed.

  PMID: 22105257 BACKGROUND

• Luo X, Lim CE, Li L, Wong WS. Hysteroscopic appearance of endometrial cavity after microwave endometrial ablation. J Minim Invasive Gynecol. 2010 Jan-Feb;17(1):30-6. doi: 10.1016/j.jmig.2009.09.012.

  PMID: 20129329 BACKGROUND

• Onoglu A, Taskin O, Inal M, Sadik S, Simsek M, Akar M, Kursun S, Mendilcioglu I, Postaci H, Ispahi C. Comparison of the long-term histopathologic and morphologic changes after endometrial rollerball ablation and resection: a prospective randomized trial. J Minim Invasive Gynecol. 2007 Jan-Feb;14(1):39-42. doi: 10.1016/j.jmig.2006.06.027.

  PMID: 17218227 BACKGROUND

• Taskin O, Onoglu A, Inal M, Turan E, Sadik S, Vardar E, Postaci H, Wheeler JM. Long-term histopathologic and morphologic changes after thermal endometrial ablation. J Am Assoc Gynecol Laparosc. 2002 May;9(2):186-90. doi: 10.1016/s1074-3804(05)60130-2.

  PMID: 11960046 BACKGROUND

• Leung PL, Tam WH, Yuen PM. Hysteroscopic appearance of the endometrial cavity following thermal balloon endometrial ablation. Fertil Steril. 2003 May;79(5):1226-8. doi: 10.1016/s0015-0282(02)04956-7.

  PMID: 12738523 BACKGROUND

• Colgan TJ, Shah R, Leyland N. Post-hysteroscopic ablation reaction: a histopathologic study of the effects of electrosurgical ablation. Int J Gynecol Pathol. 1999 Oct;18(4):325-31. doi: 10.1097/00004347-199910000-00006.

  PMID: 10542940 BACKGROUND

MeSH Terms

Conditions

Menorrhagia

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Catrina Crisp, MD, MSc

  TriHealth Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 22, 2015
• Study Start: October 11, 2016
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: December 2, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)