Effectiveness and Safety Evaluation of Aqueduct 100-device | NCT02959567

Studies
Effectiveness and Safety Evaluation of Aqueduct 100-device

NCT02959567

Sponsor

Aqueduct Medical Ltd

Status

Unknown status

Last Update Posted

Nov 9, 2016Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Cervix Uteri Dilation

Interventions

Aqueduct 100 dilation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016

Primary Completion Date

Oct 2017Estimated

Completion Date

Oct 2017Estimated

First Submitted Date

Nov 2, 2016

First Submission Date that Met QC Criteria

Nov 7, 2016

First Posted Date

Nov 9, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2016

Last Update Posted Date

Nov 9, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aqueduct 100 dilation	Experimental	Uterine cervix dilation through Aqueduct-100 device	Device: Aqueduct 100 dilation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aqueduct 100 dilation	Device		Aqueduct 100 dilation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Measurement of physicians'overall satisfaction with the device, through a questionnaire		Through study completion, an average of 11 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Larry Spiegelman, Dr.	Contact	305 595-4070		lsspmd@bellsouth.net

Overall Officials

Name	Affiliation	Role
Larry Spiegelman, Dr.	Baptist Medical Arts Surgical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Baptist Medical Arts Surgical Center, Gynecology Department		Miami	Florida	33176	United States

References Module

Citations

PubMed Identifier	Type	Citation
16143559	Background	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.
	Background	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.
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