Effectiveness and Safety Evaluation of Aqueduct -100 Device

Cervix Uteri Dilation Clinical Trial

Official title:

Effectiveness and Safety Evaluation of Aqueduct -100 Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02851953
• Other study ID #: AQD 01-15
• Status: Completed
• Phase: N/A
• First received: July 25, 2016
• Last updated: May 4, 2017
• Start date: June 2016
• Est. completion date: January 2017

Study information

• Verified date: May 2017
• Source: Aqueduct Medical Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cervix Uteri Dilation

Intervention

Device:
• Aqueduct-100

Locations

Country	Name	City	State
Italy	Irccs Azienda Ospedaliera Universitaria San Martino Ist	Genova

Sponsors (2)

Lead Sponsor	Collaborator
Aqueduct Medical Ltd	Sintesi Research Srl

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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. — View 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.

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. — View 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. Epub 2005 Sep 6. — View 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. Epub 2007 Sep 27. — View 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. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Measurement of physicians' satisfaction with the device, through the use of a questionnaire.		Through study completion, approximately 9 months