Effectiveness and Safety Evaluation of Aqueduct -100 Device

Evaluation of efficacy and safety of using Aqueduct -100 - Cervical Dilator Device

Study Overview

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

Detailed Description

There are predominantly two major dilatation techniques that are employed in dilating the cervix. The first technique uses expansible dry solid material, such as laminaria (seaweed) is inserted into the cervix in its dried stiff form. In the cervix it comes into contact with body fluids that cause the laminaria to swell and enlarge the cervical cavity. The second more widespread procedure, involves the use of series of solid, rod like instruments of graduated diameter used in serial fashion by the physician (Hegar dilators). The physician first inserts a rod like dilator and replaces it with the dilator of next higher diameter. This procedure continues until adequate dilatation occurs.

The Problem is that each of the above-mentioned methods has its shortcomings: the use of the laminaria method (rarely done) requires preliminary patient visit, for insertion of the laminaria rod and is extremely slow and typically involves often as much as 10-12 hours for a significant amount of dilatation to occur.

The use of rod-like instruments (Hegar) requires general or regional anesthesia, when local anesthetics are used, the patient nevertheless frequently experiences a great amount of discomfort from the procedure. The mechanical dilatation of the cervix demands a large amount of longitudinal force that may damage or even puncture the cervix and the uterus.

Aqueduct 100 is a catheter for use in dilating various body cavities and especially the human cervix. The device will enable continuous, fast and safe dilatation of the cervix to a pre-determined diameter as a pre-procedure to intrauterine surgeries.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Cádiz, Spain, 11500
    • Hospital General Santa Maria del Puerto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Subjects younger than 18 years of age
• Subject with sex transmitted diseases, or with infectious diseases (HIV, HCV).
• Subjects unwilling to sign the informed consent form.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

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 the diameter needed to perform the intrauterine procedure using Aqueduct-100 device.	The primary outcome of this study is to determine the efficacy of the Aqueduct-100 device to dilate the uterine cervices to the desired diameter.	Through study completion, approximately 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of Adverse Events	Safety evaluation of using Aqueduct-100	Through study completion, approximately 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 6 months
Measurement of physicians' overall satisfaction with the device through the use of a questionnaire		Through study completion, approximately 6 months

Collaborators and Investigators

• Sponsor: Aqueduct Medical Ltd
• Investigators: Principal Investigator: Javier Vico, MD, Hospital General Santa Maria del Puerto, Cádiz; Study Director: Javier Pantoja, MD, Hospital General Santa Maria del Puerto, Cádiz

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.

Helpful Links

• Aqueduct-100 functioning

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (ACTUAL): November 1, 2015
• Study Completion (ACTUAL): November 1, 2015

Study Registration Dates

• First Submitted: August 30, 2016
• First Submitted That Met QC Criteria: October 20, 2016
• First Posted (ESTIMATE): October 21, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): October 21, 2016
• Last Update Submitted That Met QC Criteria: October 20, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: balloon catheter; cervix; cervical dilation
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic
• Other Study ID Numbers: AQD 01-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: An article has been published in the digital edition of "Hysteroscopy Newsletter"