Effectiveness and Safety Evaluation of Aqueduct -100 Device
NCT ID: NCT02851953
Last Updated: 2017-05-08
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
NA
41 participants
INTERVENTIONAL
2016-06-30
2017-01-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Aqueduct 100 dilation
Uterine cervix dilation through Aqueduct-100 device
Aqueduct-100
Interventions
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Aqueduct-100
Eligibility Criteria
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Inclusion Criteria
2. Subjects undergoing any process that requires dilation (intrauterine procedures).
3. Subjects understanding the nature of the study and willing to sign informed consent form.
Exclusion Criteria
2. Subject with the following infectious diseases: HIV, HBV, HCV, Syphilis.
3. Subject has been treated with any cervix dilating agent within 2 months before the screening.
4. Known contraindications or hypersensitivity to the components of the investigational product.
5. The patient has a condition or a concurrent severe and/or uncontrolled medical disease which could compromise participation, compliance with, and/or completion with study procedures.
6. Subjects undergoing abortion \<7 and \>9 weeks of pregnancy.
7. Subjects unwilling to sign the informed consent form.
18 Years
FEMALE
No
Sponsors
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Sintesi Research Srl
INDUSTRY
Aqueduct Medical Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Pierluigi Venturini, Professor
Role: PRINCIPAL_INVESTIGATOR
IRCCS AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO IST
Simone Ferrero, Professor
Role: STUDY_DIRECTOR
IRCCS AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO IST
Locations
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Irccs Azienda Ospedaliera Universitaria San Martino Ist
Genova, , Italy
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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AQD 01-15
Identifier Type: -
Identifier Source: org_study_id
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