NCT02941211

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
Last Updated

October 21, 2016

Status Verified

October 1, 2016

Enrollment Period

10 months

First QC Date

August 30, 2016

Last Update Submit

October 20, 2016

Conditions

Cervix Uteri Dilation

Keywords

cervixcervical dilationballoon catheter

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Occurrence of Adverse Events

    Through study completion, approximately 6 months

Other Outcomes (2)

  • 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 6 months

  • Measurement of physicians' overall satisfaction with the device through the use of a questionnaire

    Through study completion, approximately 6 months

Study Arms (1)

Aqueduct 100 dilation

EXPERIMENTAL

Uterine cervix dilation through Aqueduct-100 device

Device: Aqueduct -100

Interventions

Aqueduct -100DEVICE
Aqueduct 100 dilation

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (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 willing to sign informed consent form.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General Santa Maria del Puerto

Cadiz, 11500, Spain

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: 16143559BACKGROUND

  • 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: 17904431BACKGROUND

  • 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: 3391017BACKGROUND

  • 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: 23088906BACKGROUND

  • 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: 6849849BACKGROUND

Related Links

Study Officials

  • Javier Vico, MD

    Hospital General Santa Maria del Puerto, Cádiz

    PRINCIPAL INVESTIGATOR

  • Javier Pantoja, MD

    Hospital General Santa Maria del Puerto, Cádiz

    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

August 30, 2016

First Posted

October 21, 2016

Study Start

January 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

October 21, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share

An article has been published in the digital edition of "Hysteroscopy Newsletter"

Locations

ES(1)