Clinical trial NCT02941211: Effectiveness and Safety Evaluation of Aqueduct -100 Device
Official title: Effectiveness and Safety Evaluation of Aqueduct -100 Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervix Uteri Dilation
Keywords: cervix
cervical dilation
balloon catheter
Lead sponsor: Aqueduct Medical Ltd
Sponsor class: INDUSTRY
First posted: 2016-10-21
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of patients with dilation of cervix to the diameter needed to perform the intrauterine procedure using Aqueduct-100 device.
timeFrame: Through study completion, approximately 6 months
Secondary outcomes:
measure: Occurrence of Adverse Events
timeFrame: Through study completion, approximately 6 months
Other outcomes:
measure: Time frame required to reach desired cervical dilation from start time (insertion of device) to completion of dilation (removal of catheter)
timeFrame: Through study completion, approximately 6 months
measure: Measurement of physicians' overall satisfaction with the device through the use of a questionnaire
timeFrame: Through study completion, approximately 6 months
Locations:
city: Cádiz
country: Spain
facility: Hospital General Santa Maria del Puerto
Study officials:
affiliation: Hospital General Santa Maria del Puerto, Cádiz
name: Javier Vico, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital General Santa Maria del Puerto, Cádiz
name: Javier Pantoja, MD
role: STUDY_DIRECTOR
References:
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. doi: 10.1016/j.media.2005.06.001. Epub 2005 Sep 6.
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.
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. doi: 10.1016/j.actbio.2007.04.009. Epub 2007 Sep 27.
citation: 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.
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
citation: 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.
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. doi: 10.1111/j.1471-0528.1983.tb08947.x.