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Essure no longer sold in the US after Dec 2018; Sponsor requested trial be ended
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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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The study evaluates whether saline infused sonography (SIS) with directed air bubbles for hysterosalpingo-contrast sonography (HyCoSy) is as good as or better than X-ray hysterosalpingography (HSG) for determining whether fallopian tubes are open or closed in patients who are undergoing an Essure confirmation test.
The gold standard for evaluating whether fallopian tubes are open versus closed is the X-ray hysterosalpingography (HSG). HSG is a radiologic procedure that is performed to verify that placement of the Essure tubal ligation inserts have successfully blocked the fallopian tubes. However, this procedure involved exposure to radiation. The saline infused sonography (SIS) with directed air bubbles for hysterosalpingo-contrast sonography (HyCoSy) does not involve radiation and can be done in a physician's office. The HyCoSy air bubble device may be a lower cost, safer alternative procedure if it can be shown to provide similar results for tubal patency.
This study will compare the HyCoSy procedure results with the HSG procedure results in women who require the HSG procedure after receiving Essure tubal ligation inserts for their Essure confirmation test.
Women will be randomized to receive the HycoSy procedure first, followed by the HSG procedure or to the reverse order. Two independent readers will review the video results for both procedures to determine the degree of agreement on tubal patency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 (HyCoSy followed by HSG) | Experimental | HyCoSy procedure followed by HSG procedure |
|
| Arm 2 (HSG followed by HyCoSy) | Experimental | HSG procedure followed by HyCoSy procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HyCoSy | Device | Saline infused sonogram in which air bubbles are delivered via the FemVue saline air device in order to evaluate the patency (openness) of the fallopian tubes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fallopian Tube Patency - HyCoSy vs HSG | Observed flow of fluid/bubbles through fallopian tubes. | At time of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores | Patient reported pain scale score on visual pain scale (rated 0 for no pain to 10 for severe pain with corresponding faces) | At time of procedures |
| Physician Evaluation of Uterine Cavity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Lindheim, MD | Wright State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wright State Physicians | Dayton | Ohio | 45409 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19716128 | Background | Smith RD. Contemporary hysteroscopic methods for female sterilization. Int J Gynaecol Obstet. 2010 Jan;108(1):79-84. doi: 10.1016/j.ijgo.2009.07.026. | |
| 17055838 | Background | Practice Committee of the American Society for Reproductive Medicine. Optimal evaluation of the infertile female. Fertil Steril. 2006 Nov;86(5 Suppl 1):S264-7. doi: 10.1016/j.fertnstert.2006.08.041. No abstract available. |
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No plans to share date due to small sample size
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Participants were recruited from existing practice and clinic patients who had the Essure device placed for contraception.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 (HyCoSy Followed by HSG) | HyCoSy followed by HSG HyCoSy: Saline infused sonogram in which air bubbles are delivered via the FemVue saline air device in order to evaluate the patency (openness) of the fallopian tubes |
| FG001 | Arm 2 (HSG Followed by HyCoSy) | HSG followed by HyCoSy HyCoSy: Saline infused sonogram in which air bubbles are delivered via the FemVue saline air device in order to evaluate the patency (openness) of the fallopian tubes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Test (1 Hour) |
| |||||||||||||
| Break (1 Hour) |
| |||||||||||||
| Second Test (1 Hour) |
|
Number of participants are those who completed all assessments.
Units of analysis for evaluation of the diagnostic tests is # fallopian tubes (open versus closed). All participants had 2 fallopian tubes.
| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 (HyCoSy Followed by HSG) | HyCoSy procedure followed by HSG procedure HyCoSy: Saline infused sonogram in which air bubbles are delivered via the FemVue saline air device in order to evaluate the patency (openness) of the fallopian tubes |
| BG001 | Arm 2 (HSG Followed by HyCoSy) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fallopian Tube Patency - HyCoSy vs HSG | Observed flow of fluid/bubbles through fallopian tubes. | Analysis was per fallopian tube. | Posted | Count of Units | fallopian tubes observed to be closed | At time of procedure | fallopian tubes observed to be closed | fallopian tubes observed to be closed |
|
1 week after procedures
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HyCoSy Followed by HSG | HyCoSy followed by HSG HyCoSy: Saline infused sonogram in which air bubbles are delivered via the FemVue saline air device in order to evaluate the patency (openness) of the fallopian tubes followed by: HSG performed to evaluate the patency (openness) of the fallopian tubes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Lindheim | Wright State University | 858-740-1083 | doclalalindheim@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 19, 2016 | Oct 15, 2019 | Prot_SAP_ICF_000.pdf |
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Cross over study in which participants receive one diagnostic test (SSI or HSG), then receive the other.
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Outcomes assessor does not know which procedure was received first or second.
|
Observed image of uterus (normal or not normal). Assessor commented on uterine cavity to determine whether cavity was normal versus abnormal, e.g., bicornuate uterus or any notable uterine deformity. Data were coded as "normal' or "not normal".
| At time of HyCoSy procedure |
| 15664291 | Background | Radic V, Canic T, Valetic J, Duic Z. Advantages and disadvantages of hysterosonosalpingography in the assessment of the reproductive status of uterine cavity and fallopian tubes. Eur J Radiol. 2005 Feb;53(2):268-73. doi: 10.1016/j.ejrad.2004.02.015. |
| 19027109 | Background | Veersema S, Vleugels MP, Moolenaar LM, Janssen CA, Brolmann HA. Unintended pregnancies after Essure sterilization in the Netherlands. Fertil Steril. 2010 Jan;93(1):35-8. doi: 10.1016/j.fertnstert.2008.10.005. Epub 2008 Nov 21. |
| 3371491 | Background | The American Fertility Society classifications of adnexal adhesions, distal tubal occlusion, tubal occlusion secondary to tubal ligation, tubal pregnancies, mullerian anomalies and intrauterine adhesions. Fertil Steril. 1988 Jun;49(6):944-55. doi: 10.1016/s0015-0282(16)59942-7. No abstract available. |
| 2563701 | Background | Okonofua FE, Essen UI, Nimalaraj T. Hysterosalpingography versus laparoscopy in tubal infertility: comparison based on findings at laparatomy. Int J Gynaecol Obstet. 1989 Feb;28(2):143-7. doi: 10.1016/0020-7292(89)90474-8. |
| 6211097 | Background | Musich JR, Behrman SJ. Infertility laparoscopy in perspective: review of five hundred cases. Am J Obstet Gynecol. 1982 Jun 1;143(3):293-303. doi: 10.1016/0002-9378(82)90818-3. |
| 10589406 | Background | al-Badawi IA, Fluker MR, Bebbington MW. Diagnostic laparoscopy in infertile women with normal hysterosalpingograms. J Reprod Med. 1999 Nov;44(11):953-7. |
| 7926245 | Background | Romano F, Cicinelli E, Anastasio PS, Epifani S, Fanelli F, Galantino P. Sonohysterography versus hysteroscopy for diagnosing endouterine abnormalities in fertile women. Int J Gynaecol Obstet. 1994 Jun;45(3):253-60. doi: 10.1016/0020-7292(94)90251-8. |
| 7293673 | Background | Nannini R, Chelo E, Branconi F, Tantini C, Scarselli GF. Dynamic echohysteroscopy: a new diagnostic technique in the study of female infertility. Acta Eur Fertil. 1981 Jun;12(2):165-71. No abstract available. |
| 8381140 | Background | Parsons AK, Lense JJ. Sonohysterography for endometrial abnormalities: preliminary results. J Clin Ultrasound. 1993 Feb;21(2):87-95. doi: 10.1002/jcu.1870210203. |
| 14581828 | Background | Lindheim SR, Adsuar N, Kushner DM, Pritts EA, Olive DL. Sonohysterography: a valuable tool in evaluating the female pelvis. Obstet Gynecol Surv. 2003 Nov;58(11):770-84. doi: 10.1097/01.OGX.0000094386.63363.D7. |
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| 6539931 | Background | Richman TS, Viscomi GN, deCherney A, Polan ML, Alcebo LO. Fallopian tubal patency assessed by ultrasound following fluid injection. Work in progress. Radiology. 1984 Aug;152(2):507-10. doi: 10.1148/radiology.152.2.6539931. |
| 9130913 | Background | Session DR, Lerner JP, Tchen CK, Kelly AC. Ultrasound-guided fallopian tube cannulation using Albunex. Fertil Steril. 1997 May;67(5):972-4. doi: 10.1016/s0015-0282(97)81420-3. |
| 12797192 | Background | Campbell S, Bourne TH, Tan SL, Collins WP. Hysterosalpingo contrast sonography (HyCoSy) and its future role within the investigation of infertility in Europe. Ultrasound Obstet Gynecol. 1994 May 1;4(3):245-53. doi: 10.1046/j.1469-0705.1994.04030245.x. |
| 21187197 | Background | Luciano DE, Exacoustos C, Johns DA, Luciano AA. Can hysterosalpingo-contrast sonography replace hysterosalpingography in confirming tubal blockage after hysteroscopic sterilization and in the evaluation of the uterus and tubes in infertile patients? Am J Obstet Gynecol. 2011 Jan;204(1):79.e1-5. doi: 10.1016/j.ajog.2010.08.065. |
| 22064649 | Background | Emanuel MH, van Vliet M, Weber M, Exalto N. First experiences with hysterosalpingo-foam sonography (HyFoSy) for office tubal patency testing. Hum Reprod. 2012 Jan;27(1):114-7. doi: 10.1093/humrep/der367. Epub 2011 Nov 6. |
| 9286072 | Background | Holz K, Becker R, Schurmann R. Ultrasound in the investigation of tubal patency. A meta-analysis of three comparative studies of Echovist-200 including 1007 women. Zentralbl Gynakol. 1997;119(8):366-73. |
| 7844229 | Background | Andersen AN, Yue Z, Meng FJ, Petersen K. Low implantation rate after in-vitro fertilization in patients with hydrosalpinges diagnosed by ultrasonography. Hum Reprod. 1994 Oct;9(10):1935-8. doi: 10.1093/oxfordjournals.humrep.a138362. |
| 10550881 | Background | Strandell A, Bourne T, Bergh C, Granberg S, Asztely M, Thorburn J. The assessment of endometrial pathology and tubal patency: a comparison between the use of ultrasonography and X-ray hysterosalpingography for the investigation of infertility patients. Ultrasound Obstet Gynecol. 1999 Sep;14(3):200-4. doi: 10.1046/j.1469-0705.1999.14030200.x. |
| 7371880 | Background | Stumpf PG, March CM. Febrile morbidity following hysterosalpingography: identification of risk factors and recommendations for prophylaxis. Fertil Steril. 1980 May;33(5):487-92. doi: 10.1016/s0015-0282(16)44712-6. |
| 2167499 | Background | Moore DE, Segars JH Jr, Winfield AC, Page DL, Eisenberg AD, Holburn GE. Effects of contrast agents on the fallopian tube in a rabbit model. Radiology. 1990 Sep;176(3):721-4. doi: 10.1148/radiology.176.3.2167499. |
| 1647040 | Background | Thurmond AS, Hedgpeth PL, Scanlan RM. Selective injection of contrast media: inflammatory effects on rabbit fallopian tubes. Radiology. 1991 Jul;180(1):97-9. doi: 10.1148/radiology.180.1.1647040. |
| 1848715 | Background | Lindequist S, Justesen P, Larsen C, Rasmussen F. Diagnostic quality and complications of hysterosalpingography: oil- versus water-soluble contrast media--a randomized prospective study. Radiology. 1991 Apr;179(1):69-74. doi: 10.1148/radiology.179.1.1848715. |
| 2976272 | Background | Acton CM, Devitt JM, Ryan EA. Hysterosalpingography in infertility--an experience of 3,631 examinations. Aust N Z J Obstet Gynaecol. 1988 May;28(2):127-33. doi: 10.1111/j.1479-828x.1988.tb01641.x. No abstract available. |
| 25929235 | Background | Mohiyiddeen L, Hardiman A, Fitzgerald C, Hughes E, Mol BW, Johnson N, Watson A. Tubal flushing for subfertility. Cochrane Database Syst Rev. 2015 May 1;2015(5):CD003718. doi: 10.1002/14651858.CD003718.pub4. |
| 3019786 | Background | Boyer P, Territo MC, de Ziegler D, Meldrum DR. Ethiodol inhibits phagocytosis by pelvic peritoneal macrophages. Fertil Steril. 1986 Oct;46(4):715-7. doi: 10.1016/s0015-0282(16)49657-3. No abstract available. |
| 1325928 | Background | Johnson JV, Montoya IA, Olive DL. Ethiodol oil contrast medium inhibits macrophage phagocytosis and adherence by altering membrane electronegativity and microviscosity. Fertil Steril. 1992 Sep;58(3):511-7. doi: 10.1016/s0015-0282(16)55254-6. |
| 7330172 | Background | Darby SC, Wall BF. The genetically significant dose from diagnostic radiology in Great Britain. Radiography. 1981 Sep;47(561):200-2. No abstract available. |
| 9022623 | Background | Karande VC, Pratt DE, Balin MS, Levrant SG, Morris RS, Gleicher N. What is the radiation exposure to patients during a gynecoradiologic procedure? Fertil Steril. 1997 Feb;67(2):401-3. doi: 10.1016/S0015-0282(97)81931-0. |
| 8932631 | Background | Volpi E, Zuccaro G, Patriarca A, Rustichelli S, Sismondi P. Transvaginal sonographic tubal patency testing using air and saline solution as contrast media in a routine infertility clinic setting. Ultrasound Obstet Gynecol. 1996 Jan;7(1):43-8. doi: 10.1046/j.1469-0705.1996.07010043.x. |
| 7641899 | Background | Swart P, Mol BW, van der Veen F, van Beurden M, Redekop WK, Bossuyt PM. The accuracy of hysterosalpingography in the diagnosis of tubal pathology: a meta-analysis. Fertil Steril. 1995 Sep;64(3):486-91. doi: 10.1016/s0015-0282(16)57781-4. |
| 2957237 | Background | Sulak PJ, Letterie GS, Coddington CC, Hayslip CC, Woodward JE, Klein TA. Histology of proximal tubal occlusion. Fertil Steril. 1987 Sep;48(3):437-40. |
| 19339010 | Background | Hamed HO, Shahin AY, Elsamman AM. Hysterosalpingo-contrast sonography versus radiographic hysterosalpingography in the evaluation of tubal patency. Int J Gynaecol Obstet. 2009 Jun;105(3):215-7. doi: 10.1016/j.ijgo.2009.02.001. Epub 2009 Mar 31. |
| 9486049 | Background | Chenia F, Hofmeyr GJ, Moolla S, Oratis P. Sonographic hydrotubation using agitated saline: a new technique for improving fallopian tube visualization. Br J Radiol. 1997 Aug;70(836):833-6. doi: 10.1259/bjr.70.836.9486049. |
| 14567814 | Background | Exacoustos C, Zupi E, Carusotti C, Lanzi G, Marconi D, Arduini D. Hysterosalpingo-contrast sonography compared with hysterosalpingography and laparoscopic dye pertubation to evaluate tubal patency. J Am Assoc Gynecol Laparosc. 2003 Aug;10(3):367-72. doi: 10.1016/s1074-3804(05)60264-2. |
| 11169373 | Background | Kiyokawa K, Masuda H, Fuyuki T, Koseki M, Uchida N, Fukuda T, Amemiya K, Shouka K, Suzuki K. Three-dimensional hysterosalpingo-contrast sonography (3D-HyCoSy) as an outpatient procedure to assess infertile women: a pilot study. Ultrasound Obstet Gynecol. 2000 Dec;16(7):648-54. doi: 10.1046/j.1469-0705.2000.00327.x. |
| 2526153 | Background | Deichert U, Schleif R, van de Sandt M, Juhnke I. Transvaginal hysterosalpingo-contrast-sonography (Hy-Co-Sy) compared with conventional tubal diagnostics. Hum Reprod. 1989 May;4(4):418-24. doi: 10.1093/oxfordjournals.humrep.a136920. |
| 8605765 | Background | Degenhardt F, Jibril S, Eisenhauer B. Hysterosalpingo-contrast sonography (HyCoSy) for determining tubal patency. Clin Radiol. 1996 Feb;51 Suppl 1:15-8. No abstract available. |
| 16554575 | Background | Patel MD, Acord DL, Young SW. Likelihood ratio of sonographic findings in discriminating hydrosalpinx from other adnexal masses. AJR Am J Roentgenol. 2006 Apr;186(4):1033-8. doi: 10.2214/AJR.05.0091. |
| 9853854 | Background | Reis MM, Soares SR, Cancado ML, Camargos AF. Hysterosalpingo contrast sonography (HyCoSy) with SH U 454 (Echovist) for the assessment of tubal patency. Hum Reprod. 1998 Nov;13(11):3049-52. doi: 10.1093/humrep/13.11.3049. |
| 10761336 | Background | Tanawattanacharoen S, Suwajanakorn S, Uerpairojkit B, Boonkasemsanti W, Virutamasen P. Transvaginal hysterosalpingo-contrast sonography (HyCoSy) compared with chromolaparoscopy. J Obstet Gynaecol Res. 2000 Feb;26(1):71-5. doi: 10.1111/j.1447-0756.2000.tb01205.x. |
| 14998671 | Background | Shi WT, Forsberg F, Bautista R, Vecchio C, Bernardi R, Goldberg BB. Image enhancement by acoustic conditioning of ultrasound contrast agents. Ultrasound Med Biol. 2004 Feb;30(2):191-8. doi: 10.1016/j.ultrasmedbio.2003.10.007. |
| 18262145 | Background | Connor V. Contrast infusion sonography in the post-Essure setting. J Minim Invasive Gynecol. 2008 Jan-Feb;15(1):56-61. doi: 10.1016/j.jmig.2007.07.008. |
| 12798536 | Background | Hurd WW, Wyckoff ET, Reynolds DB, Amesse LS, Gruber JS, Horowitz GM. Patient rotation and resolution of unilateral cornual obstruction during hysterosalpingography. Obstet Gynecol. 2003 Jun;101(6):1275-8. doi: 10.1016/s0029-7844(03)00361-2. |
| 19245974 | Background | Kurt M, Shaikh KA, Peterson L, Kurrelmeyer KM, Shah G, Nagueh SF, Fromm R, Quinones MA, Zoghbi WA. Impact of contrast echocardiography on evaluation of ventricular function and clinical management in a large prospective cohort. J Am Coll Cardiol. 2009 Mar 3;53(9):802-10. doi: 10.1016/j.jacc.2009.01.005. |
| 9688385 | Background | Hamilton JA, Larson AJ, Lower AM, Hasnain S, Grudzinskas JG. Evaluation of the performance of hysterosalpingo contrast sonography in 500 consecutive, unselected, infertile women. Hum Reprod. 1998 Jun;13(6):1519-26. doi: 10.1093/humrep/13.6.1519. |
| 18829020 | Background | Lanzani C, Savasi V, Leone FPG, Ratti M, Ferrazzi E. Two-dimensional HyCoSy with contrast tuned imaging technology and a second-generation contrast media for the assessment of tubal patency in an infertility program. Fertil Steril. 2009 Sep;92(3):1158-1161. doi: 10.1016/j.fertnstert.2008.07.1746. Epub 2008 Oct 1. |
| 10944037 | Background | Jeanty P, Besnard S, Arnold A, Turner C, Crum P. Air-contrast sonohysterography as a first step assessment of tubal patency. J Ultrasound Med. 2000 Aug;19(8):519-27. doi: 10.7863/jum.2000.19.8.519. |
| 32511207 | Result | Luong E, Ludwin A, Winter T, Yaklic J, Maxwell RA, Bhagavath B, Lindheim SR. Saline-Air Hysterosalpingo-Contrast Sonography Is Equivalent to the Modified Hysterosalpingogram Following Hysteroscopic Sterilization. Ultrasound Q. 2020 Jun;36(2):138-145. doi: 10.1097/RUQ.0000000000000488. |
| NOT COMPLETED |
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| NOT COMPLETED |
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HSG procedure followed by HyCoSy procedure HyCoSy: Saline infused sonogram in which air bubbles are delivered via the FemVue saline air device in order to evaluate the patency (openness) of the fallopian tubes |
| BG002 | Total | Total of all reporting groups |
| # fallopian tubes |
|
| years |
| Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
| Region of Enrollment | Number | participants | Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
| fallopian tubes observed to be closed |
|
|
|
| Secondary | Pain Scores | Patient reported pain scale score on visual pain scale (rated 0 for no pain to 10 for severe pain with corresponding faces) | Change in patient reported pain scores (pre-procedure minus post-procedure pain scores) | Posted | Mean | Standard Deviation | units on a scale | At time of procedures |
|
|
|
|
| Secondary | Physician Evaluation of Uterine Cavity | Observed image of uterus (normal or not normal). Assessor commented on uterine cavity to determine whether cavity was normal versus abnormal, e.g., bicornuate uterus or any notable uterine deformity. Data were coded as "normal' or "not normal". | Number of uteri assessed as 'normal' | Posted | Count of Participants | Participants | At time of HyCoSy procedure |
|
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Hysterosalpingogram (HSG) Followed by HyCoSy | Hysterosalpingogram (HSG) followed by HyCoSy HSG performed to evaluate the patency (openness) of the fallopian tubes followed by: HyCoSy: Saline infused sonogram in which air bubbles are delivered via the FemVue saline air device in order to evaluate the patency (openness) of the fallopian tubes | 0 | 6 | 0 | 6 | 0 | 6 |
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