Hernia, VentralNCT06051578
Abdominal Wall Tension in Patients Undergoing Ventral Hernia Repair Without Component Separation
An observational study of Hernia, Ventral and Hernia, Abdominal, run by The Cleveland Clinic at 1 site in United States.
Trial 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. 1. What is the abdominal wall tension for hernias repaired without a component separation? 2. What patient factors contribute to greater abdominal wall tension? 3. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hernia, Ventral, Hernia, Abdominal, Hernia Abdominal Wall
- What is being tested?
- Abdominal wall tension measurement
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2023to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- Patients who are planned to undergo ventral hernia repair without component separation
- Midline hernia
Who cannot join
- Mesh excision for reasons other than mesh infection
- Prior component separation
- Isolated flank hernia
- Patients under the age of 18 years
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hernia, Ventral, Hernia, Abdominal, Hernia Abdominal Wall
- Being tested
- Abdominal wall tension measurement
- Medical subject headings
- Hernia, Ventral, Hernia, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal wall tension measurementOther
All patients will have the tension of their abdominal wall measured during surgery using a tension scale or "tensiometer."
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal wall tension in patients hernia repair without component separation
The abdominal wall tension prior to closure will be measured
Measured: 2 year
Secondary outcomes (2)
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.
Measured: 2 year
Association between abdominal wall tension and patient outcomes
Abdominal wall tension will be determined and patient outcomes will be analyzed including complications, wound morbidity, recurrence
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start8 Sep 2023
- Primary completion22 May 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, VentralStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin T. Miller, The Cleveland Clinic
- Investigators
- Benjamin Miller, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051578
- Sponsor's protocol ID
- 23-857
- Status last verified
- Nov 2025
- First submitted
- 18 Sep 2023
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Wall Tension in Patients Undergoing Ventral Hernia Repair Without Component Separation
- ClinicalTrials.gov ID
- NCT06051578
- Acronym / sponsor ID
- 23-857
- Conditions
- Hernia, Ventral, Hernia, Abdominal, Hernia Abdominal Wall
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 22 May 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (2 listed)
- Patients who are planned to undergo ventral hernia repair without component separation
- Midline hernia
Key exclusion criteria (5 listed)
- Mesh excision for reasons other than mesh infection
- Prior component separation
- Isolated flank hernia
- Patients under the age of 18 years
- Pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal wall tension measurementAll patients will have the tension of their abdominal wall measured during surgery using a tension scale or "tensiometer." | Other | – |
Primary outcome
Abdominal wall tension in patients hernia repair without component separation
Time frame: 2 year
The abdominal wall tension prior to closure will be measured
2 secondary outcomes
Patient factors that contribute to greater abdominal wall tension
Time frame: 2 year
Association between abdominal wall tension and patient outcomes
Time frame: 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Miller, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia, Ventral and Hernia, Abdominal, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal wall tension in patients hernia repair without component separation (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.