Effectiveness and Safety Evaluation of Aqueduct 100-device

November 7, 2016 updated by: Aqueduct Medical Ltd
Evaluation of efficacy and safety of using Aqueduct -100 - Cervical Dilator Device, focusing on diagnostic or operative hysteroscopies.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33176
        • Baptist Medical Arts Surgical Center, Gynecology Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aqueduct 100 dilation
Uterine cervix dilation through Aqueduct-100 device
Device: Aqueduct 100 dilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: Through study completion, an average of 11 months
Efficacy evaluation of Aqueduct-100
Through study completion, an average of 11 months
Occurrence of Adverse Events
Time Frame: Through study completion, an average of 11 months
In vivo safety evaluation of using Aqueduct-100
Through study completion, an average of 11 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aqueduct Medical Ltd

Investigators

  • Principal Investigator: Larry Spiegelman, Dr., Baptist Medical Arts Surgical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

November 2, 2016

First Submitted That Met QC Criteria

November 7, 2016

First Posted (Estimate)

November 9, 2016

Study Record Updates

Last Update Posted (Estimate)

November 9, 2016

Last Update Submitted That Met QC Criteria

November 7, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AQD 01-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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