Demonstrate the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse

• Sponsor: Lyra Medical Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02209337
• Collaborator: (none)
• Enrollment: 20
• Locations: 3
• Arm: 1
• Actual Duration (Months): 42
• Patients Per Site: 6.7
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

A prospective, single arm, pre-market, multi-center clinical study to evaluate the safety and performance of the SRS (Lyra Medical) vaginal mesh in POP patients

Condition or Disease	Intervention/Treatment	Phase
Anterior Vaginal Wall Prolapse; Vaginal Apex/Uterine Prolapse	Device: SRS	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Demonstrate the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse
• Actual Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SRS-I Implantation of SRS-I	Device: SRS

Outcome Measures

Primary Outcome Measures

1. No device related serious adverse events [up to 12 month]

Secondary Outcome Measures

1. Minimal rate of device or procedure adverse events (intra and post operative Minimal rate of device or procedure adverse events (intra and post operative complications) [up to 12 months]

2. Improvement in POP-Q: points Aa and Ba [up to 12 month]

3. Improvement in POP-Q point C [up to 12 months]

4. Achieving normal urinary function [up to 12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patient has signed the informed consent form and is willing to participate in the clinical study and data collection.

2. Patient age is between 18 and 75 years old

3. POP-Q: Aa and/or Ba is at least -1

Exclusion Criteria:

1. Patient is pregnant or breastfeeding

2. Patient suffering from active infection (on antibiotic therapy)

3. Patient planning vaginal delivery

4. Patient had Previous vaginal mesh surgery

5. Patient is in high risk for surgery (evidence of clinically significant cardiovascular, renal, hepatic or respiratory diseases).

6. Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.

7. Malignancy .

8. Known hypersensitivity to PEEK and polypropylene materials.

9. Participation in another investigational trial that has not completed the primary endpoint or interferes with study participation.

10. Tendency for hyper-scaring reaction

11. Diagnosed with mental or emotional disturbance.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Szeged	Szeged		Hungary
2	Mayanei HaYeshua Medical Center	Bnei Brak		Israel	51544
3	Asaf HaRofeh Medical Center	Zrifin		Israel	70300

Sponsors and Collaborators

• Lyra Medical Ltd.

Investigators

• Principal Investigator: Gil Levi, Dr., Mayanei HaYeshua Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lyra Medical Ltd.
• ClinicalTrials.gov Identifier: NCT02209337
• Other Study ID Numbers: CD-14-005
• First Posted: Aug 5, 2014
• Last Update Posted: Aug 16, 2019
• Last Verified: Aug 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Uterine Prolapse; Prolapse; Pelvic Organ Prolapse

Study Results

No Results Posted as of Aug 16, 2019