ContraceptionHyCoSyNCT02628873
Can SIS Using Air Bubbles Replace HSG for Fallopian Tubal Patency After Essure Placement
A study testing HyCoSy in people with Contraception, run by Wright State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Contraception
- What is being tested?
- HyCoSy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documentation of normal Pap smear within 1 year prior to enrollment into study.
- Written informed consent given
- Need for evaluation of tubal status for post-Essure tubal occlusion
- Negative urine pregnancy test
Who cannot join
- History of unresolved dysfunctional uterine bleeding (DUB).
- History of a hysterectomy.
- Current urogenital disease.
- History of allergic response to IVP dye (exclusion for HSG).
- Abnormal pap smear.
- Positive urine pregnancy test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Contrast Infused Sonography Using Air Bubbles Replace Hysterosalpingogram as the Diagnostic Evaluation of Fallopian Tube Patency Following Hysteroscopic Sterilization Using Essure
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.
Read the detailed description
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.
- Conditions
- Contraception
- Being tested
- HyCoSy
- Keywords
- HSG, HyCoSy, Contraception, Essure, Saline Infused sonography, SIS, Air bubbles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyCoSyDevice
Also called Fem Vue, Saline Air Device, Saline infused sonogram
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
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (HyCoSy followed by HSG) | Experimental | HyCoSy procedure followed by HSG procedure Receives: Device: HyCoSy |
| Arm 2 (HSG followed by HyCoSy) | Experimental | HSG procedure followed by HyCoSy procedure Receives: Device: HyCoSy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fallopian Tube Patency - HyCoSy vs HSG
Observed flow of fluid/bubbles through fallopian tubes.
Measured: At time of procedure
Secondary outcomes (2)
Pain Scores
Patient reported pain scale score on visual pain scale (rated 0 for no pain to 10 for severe pain with corresponding faces)
Measured: At time of procedures
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".
Measured: At time of HyCoSy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionSep 2018
- Study completionOct 2018
Why it stopped: Essure no longer sold in the US after Dec 2018; Sponsor requested trial be ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (51)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cross over study in which participants receive one diagnostic test (SSI or HSG), then receive the other.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wright State University
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Steven Lindheim, MD, Principal investigator, Wright State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628873
- Sponsor's protocol ID
- Lindheim2015-01
- Acronym
- HyCoSy
- Status last verified
- Oct 2024
- First submitted
- 5 Oct 2015
- Last updated
- 22 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plans to share date due to small sample size
Publications
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.
PubMed 19716128Practice 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.
PubMed 17055838Radic 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.
PubMed 15664291Veersema 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.
PubMed 19027109The 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.
PubMed 3371491Okonofua 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.
PubMed 2563701Musich 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.
PubMed 6211097al-Badawi IA, Fluker MR, Bebbington MW. Diagnostic laparoscopy in infertile women with normal hysterosalpingograms. J Reprod Med. 1999 Nov;44(11):953-7.
PubMed 10589406Romano 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.
PubMed 7926245Nannini 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.
PubMed 7293673Parsons AK, Lense JJ. Sonohysterography for endometrial abnormalities: preliminary results. J Clin Ultrasound. 1993 Feb;21(2):87-95. doi: 10.1002/jcu.1870210203.
PubMed 8381140Lindheim 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.
PubMed 14581828Mitri FF, Andronikou AD, Perpinyal S, Hofmeyr GJ, Sonnendecker EW. A clinical comparison of sonographic hydrotubation and hysterosalpingography. Br J Obstet Gynaecol. 1991 Oct;98(10):1031-6. doi: 10.1111/j.1471-0528.1991.tb15342.x.
PubMed 1751435Richman 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.
PubMed 6539931Session 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.
PubMed 9130913
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Contrast Infused Sonography Using Air Bubbles Replace Hysterosalpingogram as the Diagnostic Evaluation of Fallopian Tube Patency Following Hysteroscopic Sterilization Using Essure
- ClinicalTrials.gov ID
- NCT02628873
- Acronym / sponsor ID
- HyCoSy / Lindheim2015-01
- Conditions
- Contraception
- Keywords
- HSG, HyCoSy, Contraception, Essure, Saline Infused sonography, SIS, Air bubbles
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Essure no longer sold in the US after Dec 2018; Sponsor requested trial be ended
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Wright State UniversityUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Dec 2015 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 11 Dec 2015 (estimated)
- Results
- Posted 31 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cross over study in which participants receive one diagnostic test (SSI or HSG), then receive the other.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (HyCoSy followed by HSG) | Experimental | Device: HyCoSyHyCoSy procedure followed by HSG procedure |
| Arm 2 (HSG followed by HyCoSy) | Experimental | Device: HyCoSyHSG procedure followed by HyCoSy procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Documentation of normal Pap smear within 1 year prior to enrollment into study.
- Written informed consent given
- Need for evaluation of tubal status for post-Essure tubal occlusion
- Negative urine pregnancy test
Key exclusion criteria (6 listed)
- History of unresolved dysfunctional uterine bleeding (DUB).
- History of a hysterectomy.
- Current urogenital disease.
- History of allergic response to IVP dye (exclusion for HSG).
- Abnormal pap smear.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HyCoSyAlso: Fem Vue, Saline Air Device, Saline infused sonogramSaline 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 | Device | Arm 1 (HyCoSy followed by HSG), Arm 2 (HSG followed by HyCoSy) |
Primary outcome
Fallopian Tube Patency - HyCoSy vs HSG
Time frame: At time of procedure
Observed flow of fluid/bubbles through fallopian tubes.
2 secondary outcomes
Pain Scores
Time frame: At time of procedures
Physician Evaluation of Uterine Cavity
Time frame: At time of HyCoSy procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19716128Smith 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.
- Background: PubMed 17055838Practice 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.
- Background: PubMed 15664291Radic 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.
- Background: PubMed 19027109Veersema 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.
- Background: PubMed 3371491The 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.
- Background: PubMed 2563701Okonofua 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.
- Background: PubMed 6211097Musich 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.
- Background: PubMed 10589406al-Badawi IA, Fluker MR, Bebbington MW. Diagnostic laparoscopy in infertile women with normal hysterosalpingograms. J Reprod Med. 1999 Nov;44(11):953-7.
- Background: PubMed 7926245Romano 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.
- Background: PubMed 7293673Nannini 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.
- Background: PubMed 8381140Parsons AK, Lense JJ. Sonohysterography for endometrial abnormalities: preliminary results. J Clin Ultrasound. 1993 Feb;21(2):87-95. doi: 10.1002/jcu.1870210203.
- Background: PubMed 14581828Lindheim 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.
- Individual participant dataSharing planned: No. No plans to share date due to small sample size
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Lindheim, MD principal investigator
Wright State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HyCoSy in people with Contraception, run by Wright State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fallopian Tube Patency - HyCoSy vs HSG (time frame: At time of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02628873, which also lists 51 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.