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: NCT02941211
• Other study ID #: AQD 01-14
• Status: Completed
• Phase: N/A
• First received: August 30, 2016
• Last updated: October 20, 2016
• Start date: January 2015
• Est. completion date: November 2015

Study information

• Verified date: October 2016
• Source: Aqueduct Medical Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics CommitteeSpain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervix Uteri Dilation

Intervention

Device:
• Aqueduct -100

Locations

Country	Name	City	State
Spain	Hospital General Santa Maria del Puerto	Cádiz

Sponsors (1)

Lead Sponsor	Collaborator
Aqueduct Medical Ltd

Country where clinical trial is conducted

Spain, 

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
Other	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	No
Other	Measurement of physicians' overall satisfaction with the device through the use of a questionnaire		Through study completion, approximately 6 months	No
Primary	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	No
Secondary	Occurrence of Adverse Events	Safety evaluation of using Aqueduct-100	Through study completion, approximately 6 months	Yes

External Links

•   Aqueduct-100 functioning