Ultrasound Appearance of the Endometrium Post Radio-Frequency Ablation
NCT ID: NCT02584088
Last Updated: 2022-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
80 participants
OBSERVATIONAL
2016-10-11
2021-11-30
Brief Summary
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* Secondary aims include correlation of ultrasonographic findings to demographic patient data.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Ultrasound
The appearance of the post ablative endometrium on transvaginal ultrasound at 2, 6, and 12 months.
Eligibility Criteria
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Inclusion Criteria
* 18 years and older
* intended ablative management of menorrhagia
Exclusion Criteria
* 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.
18 Years
FEMALE
Yes
Sponsors
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TriHealth Inc.
OTHER
Responsible Party
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Principal Investigators
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Catrina Crisp, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
TriHealth Inc.
Locations
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Good Samaritan Hospital
Cincinnati, Ohio, United States
Bethesda North Hospital
Cincinnati, Ohio, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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15-029
Identifier Type: -
Identifier Source: org_study_id
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