NCT04764760

Brief Summary

"A bio-mechanically compatible, minimally invasive technique for recurrence-free groin hernia repair by implantation of Tensiflex mesh prosthesis for the enhancement of the tissue tensile strength of the fascia transversalis."

Trial Health

87
On Track

Trial Health Score

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

Enrollment
486

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 1987

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 1987

Completed
14 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2001

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2001

Completed
20.1 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

14 years

First QC Date

February 18, 2021

Last Update Submit

February 18, 2021

Conditions

Inguinal Hernia

Keywords

tensile strength augmentation.

Outcome Measures

Primary Outcomes (1)

  • Recurrence free outcome

    The prospective study of 486 patients includes implantation of the specially designed Tensiflex mesh prosthesis in117 patients for seamless augmentation of the tensile strength,has rendered 100% recurrence free oucomes.

    5 years

Study Arms (2)

Phase 1:Study role tissue tensile strength

OTHER

The tensile strength of the orifice of Frauchad was augmented by implantation of a Accordion fold shaped prosthesis.

Device: Wing shaped Tensiflex prosthesis

Phase 2:Curative implantation of a custom designed bio-mechanically compatible Tensiflex prosthesis

OTHER

The wing shaped custom designed tensiflex prosthesis in the groin was impanted as a curative technique since it provided seamless augmenation of the tensile tissue strength.

Device: Wing shaped Tensiflex prosthesis

Interventions

Wing shaped Tensiflex prosthesisDEVICE

Curative inguinal hernia repair techniqque

Phase 1:Study role tissue tensile strengthPhase 2:Curative implantation of a custom designed bio-mechanically compatible Tensiflex prosthesis

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all patients with confirmed groin hernia of both sexes.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St.Joseph Mercy Oakland Pontiac

Pontiac, Michigan, 48341, United States

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Narendra Tyagi, MD FACS

    St.Joseph Mercy Oakland Pontiac

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All patients with confirmed inguinal hernias of all types
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Former Chairman of surgery St. Joseph Mercy Oakland Hospital

Study Record Dates

First Submitted

February 18, 2021

First Posted

February 21, 2021

Study Start

January 1, 1987

Primary Completion

January 1, 2001

Study Completion

February 1, 2001

Last Updated

February 21, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

All collected IPD

Shared Documents
STUDY PROTOCOL
Time Frame
Starting immediately after publication
Access Criteria
All surgeons

Locations

US(1)