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Effectiveness and Safety Evaluation of Aqueduct -100 Device

Primary Purpose

Cervix Uteri Dilation

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Aqueduct-100
Sponsored by
Aqueduct Medical Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervix Uteri Dilation focused on measuring cervix, cervical dilation, balloon catheter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects, females, 18 years of age or older.
  2. Subjects undergoing any process that requires dilation (intrauterine procedures).
  3. Subjects understanding the nature of the study and willing to sign informed consent form.

Exclusion Criteria:

  1. Subjects younger than 18 years of age.
  2. Subject with the following infectious diseases: HIV, HBV, HCV, Syphilis.
  3. Subject has been treated with any cervix dilating agent within 2 months before the screening.
  4. Known contraindications or hypersensitivity to the components of the investigational product.
  5. The patient has a condition or a concurrent severe and/or uncontrolled medical disease which could compromise participation, compliance with, and/or completion with study procedures.
  6. Subjects undergoing abortion <7 and >9 weeks of pregnancy.
  7. Subjects unwilling to sign the informed consent form.

Sites / Locations

  • Irccs Azienda Ospedaliera Universitaria San Martino Ist

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aqueduct 100 dilation

Arm Description

Uterine cervix dilation through Aqueduct-100 device

Outcomes

Primary Outcome Measures

Percentage of patients with dilation of cervix to a pre-determined diameter before the intrauterine procedure using Aqueduct-100 device.
The primary outcome of this study is to determine the effectiveness of the Aqueduct-100 device to dilate the uterine cervices to the desired diameter.

Secondary Outcome Measures

Occurrence of Adverse Events: rate, list and severity of AEs and SAEs.
In vivo safety evaluation of using Aqueduct-100.
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.
Measurement of physicians' satisfaction with the device, through the use of a questionnaire.

Full Information

First Posted
July 25, 2016
Last Updated
May 4, 2017
Sponsor
Aqueduct Medical Ltd
Collaborators
Sintesi Research Srl
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1. Study Identification

Unique Protocol Identification Number
NCT02851953
Brief Title
Effectiveness and Safety Evaluation of Aqueduct -100 Device
Official Title
Effectiveness and Safety Evaluation of Aqueduct -100 Device
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aqueduct Medical Ltd
Collaborators
Sintesi Research Srl

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the present clinical investigation is to collect data regarding the safety and effectiveness of the Aqueduct 100 device. The effectiveness of the Aqueduct 100 will be determined by evaluating the ability to reach desired cervical dilation, and the time frame required to reach desired cervical dilation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervix Uteri Dilation
Keywords
cervix, cervical dilation, balloon catheter

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aqueduct 100 dilation
Arm Type
Experimental
Arm Description
Uterine cervix dilation through Aqueduct-100 device
Intervention Type
Device
Intervention Name(s)
Aqueduct-100
Primary Outcome Measure Information:
Title
Percentage of patients with dilation of cervix to a pre-determined diameter before the intrauterine procedure using Aqueduct-100 device.
Description
The primary outcome of this study is to determine the effectiveness of the Aqueduct-100 device to dilate the uterine cervices to the desired diameter.
Time Frame
Through study completion, approximately 9 months
Secondary Outcome Measure Information:
Title
Occurrence of Adverse Events: rate, list and severity of AEs and SAEs.
Description
In vivo safety evaluation of using Aqueduct-100.
Time Frame
Through study completion, approximately 9 months
Title
Time frame required to reach desired cervical dilation from start time (insertion of device) to completion of dilation (removal of catheter)
Description
Duration of the dilation procedure.
Time Frame
Through study completion, approximately 9 months
Title
Measurement of physicians' satisfaction with the device, through the use of a questionnaire.
Time Frame
Through study completion, approximately 9 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects, females, 18 years of age or older. Subjects undergoing any process that requires dilation (intrauterine procedures). Subjects understanding the nature of the study and willing to sign informed consent form. Exclusion Criteria: Subjects younger than 18 years of age. Subject with the following infectious diseases: HIV, HBV, HCV, Syphilis. Subject has been treated with any cervix dilating agent within 2 months before the screening. Known contraindications or hypersensitivity to the components of the investigational product. The patient has a condition or a concurrent severe and/or uncontrolled medical disease which could compromise participation, compliance with, and/or completion with study procedures. Subjects undergoing abortion <7 and >9 weeks of pregnancy. Subjects unwilling to sign the informed consent form.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierluigi Venturini, Professor
Organizational Affiliation
IRCCS AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO IST
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Simone Ferrero, Professor
Organizational Affiliation
IRCCS AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO IST
Official's Role
Study Director
Facility Information:
Facility Name
Irccs Azienda Ospedaliera Universitaria San Martino Ist
City
Genova
ZIP/Postal Code
16132
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
16143559
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.
Results Reference
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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.
Results Reference
background
PubMed Identifier
17904431
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.
Results Reference
background
PubMed Identifier
3391017
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
23088906
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.
Results Reference
background
PubMed Identifier
6849849
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.
Results Reference
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Effectiveness and Safety Evaluation of Aqueduct -100 Device

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