Abdominal Wall Tension in Patients Undergoing Ventral Her... | NCT06051578

Studies
Abdominal Wall Tension in Patients Undergoing Ventral Hernia Repair Without Component Separation

NCT06051578

Sponsor

The Cleveland Clinic

Status

Active, not recruiting

Last Update Posted

Dec 3, 2025Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Hernia, Ventral
Hernia, Abdominal
Hernia Abdominal Wall

Interventions

Abdominal wall tension measurement

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 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 8, 2023Actual

Primary Completion Date

May 22, 2025Actual

Completion Date

May 1, 2026Estimated

First Submitted Date

Sep 18, 2023

First Submission Date that Met QC Criteria

Sep 18, 2023

First Posted Date

Sep 25, 2023Actual

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 25, 2025

Last Update Posted Date

Dec 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

The purpose of this study is to use a scale to learn more about the tension of the abdominal wall in hernia repairs without component separation.

What is the abdominal wall tension for hernias repaired without a component separation?
What patient factors contribute to greater abdominal wall tension?
Is there an association between abdominal wall tension before primary closure or bridging repair and patient outcomes?

Participants will be asked to allow their surgeon to use a tension scale to measure the tension of the abdominal wall during surgery.

Detailed Description

This is a prospective cohort study. Patients who undergo hernia repair without component separation will have their abdominal wall tension measured using a tension scale. The scale is an investigational (experimental) device that works by attaching to surgical clamps during surgery to measure the tension on the abdominal wall. The study operations will be performed at Cleveland Clinic by six hernia surgeons with advanced abdominal wall reconstruction training.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Abdominal wall tension measurement	Other	All patients will have the tension of their abdominal wall measured during surgery using a tension scale or "tensiometer."

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Abdominal wall tension in patients hernia repair without component separation	The abdominal wall tension prior to closure will be measured	2 year

Secondary Outcomes

Measure	Description	Time Frame
Patient factors that contribute to greater abdominal wall tension	Patient demographics, comorbidities, operative history, operative details, hernia size and width and abdominal wall tension will be collected and analyzed to determine what factors contribute to abdominal wall tension.	2 year
Association between abdominal wall tension and patient outcomes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who are planned to undergo ventral hernia repair without component separation
Midline hernia

Exclusion Criteria:

Mesh excision for reasons other than mesh infection
Prior component separation
Isolated flank hernia
Patients under the age of 18 years
Pregnant patients

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The study population will consist of 50 patients who have been evaluated by a surgeon and will undergo a hernia repair without component separation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Benjamin Miller, MD	The Cleveland Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cleveland Clinic Foundation		Cleveland	Ohio	44195	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006555	Hernia, Ventral
D046449	Hernia, Abdominal

Ancestor Terms

ID	Term
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided