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: Not yet recruiting

Administrative data

• NCT number: NCT02959567
• Other study ID #: AQD 01-04
• Status: Not yet recruiting
• Phase: N/A
• First received: November 2, 2016
• Last updated: November 7, 2016
• Start date: November 2016
• Est. completion date: October 2017

Study information

• Verified date: November 2016
• Source: Aqueduct Medical Ltd
• Contact: Larry Spiegelman, Dr.
• Phone: 305 595-4070
• Email: lsspmd[@]bellsouth.net
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Evaluation of efficacy and safety of using Aqueduct -100 - Cervical Dilator Device, focusing on diagnostic or operative hysteroscopies.

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: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects, females, 18 years of age or older.

• Subjects undergoing diagnostic or operative hysteroscopies

• Subjects willing to sign informed consent form.

Exclusion Criteria:

• Subjects younger than 18 years of age

• Subjects unwilling to sign the informed consent form

• Pregnancy

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 dilation

Locations

Country	Name	City	State
United States	Baptist Medical Arts Surgical Center, Gynecology Department	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Aqueduct Medical Ltd

Country where clinical trial is conducted

United States, 

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. — 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. — 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 in which, through 1 minute dilation with Aqueduct-100, a cervix dilation of 5mm, required for diagnostic/ operative hysteroscopy, is reached.	Efficacy evaluation of Aqueduct-100	Through study completion, an average of 11 months	No
Primary	Occurrence of Adverse Events	In vivo safety evaluation of using Aqueduct-100	Through study completion, an average of 11 months	Yes
Secondary	Measurement of physicians'overall satisfaction with the device, through a questionnaire		Through study completion, an average of 11 months	No