Effectiveness and Safety Evaluation of Aqueduct -100 Device

NCT02851953 | Completed

• 1 other identifier: AQD 01-15
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervix Uteri Dilation

Keywords

cervix, cervical dilation, balloon catheter

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Occurrence of Adverse Events: rate, list and severity of AEs and SAEs.

  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)

  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

Study Arms (1)

Aqueduct 100 dilation

EXPERIMENTAL

Uterine cervix dilation through Aqueduct-100 device

Device: Aqueduct-100

Interventions

Aqueduct-100 DEVICE

Aqueduct 100 dilation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects, females, 18 years of age or older.
• Subjects undergoing any process that requires dilation (intrauterine procedures).
• Subjects understanding the nature of the study and willing to sign informed consent form.

You may not qualify if:

• Subjects younger than 18 years of age.
• Subject with the following infectious diseases: HIV, HBV, HCV, Syphilis.
• Subject has been treated with any cervix dilating agent within 2 months before the screening.
• Known contraindications or hypersensitivity to the components of the investigational product.
• 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.
• Subjects undergoing abortion \<7 and \>9 weeks of pregnancy.
• Subjects unwilling to sign the informed consent form.

Sponsors & Collaborators

• Aqueduct Medical Ltd: lead
• Sintesi Research Srl: collaborator

Study Sites (1)

Irccs Azienda Ospedaliera Universitaria San Martino Ist

Genova, 16132, Italy

Location

Related Publications (7)

• 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.

  PMID: 16143559 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.

  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.

  PMID: 17904431 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.

  PMID: 3391017 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.

  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.

  PMID: 23088906 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.

  PMID: 6849849 BACKGROUND

Study Officials

• Pierluigi Venturini, Professor

  IRCCS AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO IST

  PRINCIPAL INVESTIGATOR

• Simone Ferrero, Professor

  IRCCS AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO IST

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: August 2, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: May 8, 2017

Record last verified: 2017-05

Locations

IT (1)