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| Name | Class |
|---|---|
| Sintesi Research Srl | INDUSTRY |
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The purpose of the present clinical investigation is to collect data regarding the safety and effectiveness of the Aqueduct 100 device.
The effectiveness of the Aqueduct 100 will be determined by evaluating the ability to reach desired cervical dilation, and the time frame required to reach desired cervical dilation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aqueduct 100 dilation | Experimental | Uterine cervix dilation through Aqueduct-100 device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aqueduct-100 | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with dilation of cervix to a pre-determined diameter before the intrauterine procedure using Aqueduct-100 device. | The primary outcome of this study is to determine the effectiveness of the Aqueduct-100 device to dilate the uterine cervices to the desired diameter. | Through study completion, approximately 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Adverse Events: rate, list and severity of AEs and SAEs. | In vivo safety evaluation of using Aqueduct-100. | Through study completion, approximately 9 months |
| Time frame required to reach desired cervical dilation from start time (insertion of device) to completion of dilation (removal of catheter) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierluigi Venturini, Professor | IRCCS AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO IST | Principal Investigator |
| Simone Ferrero, Professor | IRCCS AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO IST | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irccs Azienda Ospedaliera Universitaria San Martino Ist | Genova | 16132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16143559 | Background | Mazza E, Nava A, Bauer M, Winter R, Bajka M, Holzapfel GA. Mechanical properties of the human uterine cervix: an in vivo study. Med Image Anal. 2006 Apr;10(2):125-36. doi: 10.1016/j.media.2005.06.001. Epub 2005 Sep 6. | |
| Background | Buhimschi, C.; Buhimschi, I.; Malinow, A.; Saade, G.; Garfield, R.; Weiner, C., The Forces of Labour. Fetal and Maternal Medicine Review 2003, 14 (4), 273-307. | ||
| 17904431 |
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Duration of the dilation procedure. |
| Through study completion, approximately 9 months |
| Measurement of physicians' satisfaction with the device, through the use of a questionnaire. | Through study completion, approximately 9 months |
| Background |
| Myers KM, Paskaleva AP, House M, Socrate S. Mechanical and biochemical properties of human cervical tissue. Acta Biomater. 2008 Jan;4(1):104-16. doi: 10.1016/j.actbio.2007.04.009. Epub 2007 Sep 27. |
| 3391017 | Background | Kenyon NJ, Stevens JC, Stewart P, Black MM, Clifford A. A critical investigation of the measurement of the force required to dilate the human uterine cervix. Clin Phys Physiol Meas. 1988 May;9(2):155-61. doi: 10.1088/0143-0815/9/2/008. |
| Background | S. Febvay, S. Socrate and M.D. House. Biomechanical modeling of cervical tissue. A quantitative investigation of cervical funneling. Proceedings of the ASME 2003 International Mechanical Engineering Congress and Exposition, Washington, D.C., November 2003. |
| 23088906 | Background | Arsenijevic S, Vukcevic-Globarevic G, Volarevic V, Macuzic I, Todorovic P, Tanaskovic I, Mijailovic M, Raicevic S, Jeremic B. Continuous controllable balloon dilation: a novel approach for cervix dilation. Trials. 2012 Oct 22;13:196. doi: 10.1186/1745-6215-13-196. |
| 6849849 | Background | Nicolaides KH, Welch CC, MacPherson MB, Johnson IR, Filshie GM. Lamicel: a new technique for cervical dilatation before first trimester abortion. Br J Obstet Gynaecol. 1983 May;90(5):475-9. doi: 10.1111/j.1471-0528.1983.tb08947.x. |