Effectiveness and Safety Evaluation of Aqueduct -100 Device

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.

Study Overview

• Status: Completed
• Conditions: Cervix Uteri Dilation
• Intervention / Treatment: Device: Aqueduct-100

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Genova, Italy, 16132
    • IRCCS Azienda Ospedaliera Universitaria San Martino IST

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aqueduct 100 dilation; Uterine cervix dilation through Aqueduct-100 device	Device: Aqueduct-100

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Aqueduct Medical Ltd
• Collaborators: Sintesi Research Srl
• Investigators: Principal Investigator: Pierluigi Venturini, Professor, IRCCS Azienda Ospedaliera Universitaria San Martino IST; Study Director: Simone Ferrero, Professor, IRCCS Azienda Ospedaliera Universitaria San Martino IST

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: July 25, 2016
• First Submitted That Met QC Criteria: July 28, 2016
• First Posted (Estimate): August 2, 2016

Study Record Updates

• Last Update Posted (Actual): May 8, 2017
• Last Update Submitted That Met QC Criteria: May 4, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: cervix, cervical dilation, balloon catheter
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic
• Other Study ID Numbers: AQD 01-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED