Clinical trial NCT02851953: Effectiveness and Safety Evaluation of Aqueduct -100 Device
Official title: Effectiveness and Safety Evaluation of Aqueduct -100 Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervix Uteri Dilation
Keywords: cervix, cervical dilation, balloon catheter
Lead sponsor: Aqueduct Medical Ltd
Sponsor class: INDUSTRY
Collaborators: name: Sintesi Research Srl
First posted: 2016-08-02
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Subjects, females, 18 years of age or older.
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:

1. Subjects younger than 18 years of age.
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.

Primary outcomes:
measure: Percentage of patients with dilation of cervix to a pre-determined diameter before the intrauterine procedure using Aqueduct-100 device.
timeFrame: Through study completion, approximately 9 months
Secondary outcomes:
measure: Occurrence of Adverse Events: rate, list and severity of AEs and SAEs.
timeFrame: Through study completion, approximately 9 months
measure: Time frame required to reach desired cervical dilation from start time (insertion of device) to completion of dilation (removal of catheter)
timeFrame: Through study completion, approximately 9 months
measure: Measurement of physicians' satisfaction with the device, through the use of a questionnaire.
timeFrame: Through study completion, approximately 9 months
Other outcomes:
Locations:
city: Genova
country: Italy
facility: Irccs Azienda Ospedaliera Universitaria San Martino Ist
Study officials:
affiliation: IRCCS AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO IST
name: Pierluigi Venturini, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO IST
name: Simone Ferrero, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.