NCT02959567

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

November 9, 2016

Status Verified

November 1, 2016

Enrollment Period

11 months

First QC Date

November 2, 2016

Last Update Submit

November 7, 2016

Conditions

Cervix Uteri Dilation

Keywords

cervixcervical dilationballoon catheter

Outcome Measures

Primary Outcomes (2)

  • 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

  • Occurrence of Adverse Events

    In vivo safety evaluation of using Aqueduct-100

    Through study completion, an average of 11 months

Secondary Outcomes (1)

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

    Through study completion, an average of 11 months

Study Arms (1)

Aqueduct 100 dilation

EXPERIMENTAL

Uterine cervix dilation through Aqueduct-100 device

Device: Aqueduct 100 dilation

Interventions

Aqueduct 100 dilationDEVICE
Aqueduct 100 dilation

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects, females, 18 years of age or older.
  • Subjects undergoing diagnostic or operative hysteroscopies
  • Subjects willing to sign informed consent form.

You may not qualify if:

  • Subjects younger than 18 years of age
  • Subjects unwilling to sign the informed consent form
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baptist Medical Arts Surgical Center, Gynecology Department

Miami, Florida, 33176, United States

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

Study Officials

  • Larry Spiegelman, Dr.

    Baptist Medical Arts Surgical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Larry Spiegelman, Dr.

CONTACT

305 595-4070lsspmd@bellsouth.net

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

November 2, 2016

First Posted

November 9, 2016

Study Start

November 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

November 9, 2016

Record last verified: 2016-11

Locations

US(1)