Hernia, VentralATLASNCT02712398
A Prospective Trial of a Bio-absorbable Mesh in Challenging Laparoscopic Ventral or Incisional Hernia Repair
A study testing Phasix™ ST in people with Hernia, Ventral and Incisional Hernia, run by C. R. Bard at 16 sites in United States.
Trial summary
The objective of this study is to collect additional data on safety, performance and effectiveness of Phasix™ ST in subjects receiving laparoscopic ventral or incisional hernia repair at high risk for surgical site occurrence (SSO). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Ventral, Incisional Hernia
- What is being tested?
- Phasix™ ST
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 16 sitesUnited States
- Study dates
- Apr 2016to 15 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be 18 years of age or older
- Subject must be willing to give written informed consent
- Subject must be diagnosed with ventral or abdominal incisional hernia
- Subject must be willing to undergo laparoscopic hernia repair using intraabdominal placement (with or without Component Separation Technique (CST))
- Surgeon must be able to fully close the hernia defect. Defect closure is defined as complete reapproximation of fascial edges, leaving no gap. Since the safety and effectiveness of Phasix™ ST Mesh in bridging repairs has not been evaluated or established, the defect should be closed prior to mesh use.
- Subject is expected to meet the criteria for a Class I wound
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- Subjects must have 1 or more of the following pre-study conditions:
- Body Mass Index (BMI) between 30-40 kg/m2, inclusive
- Active smoker (including if attempts to quit smoking within two weeks of surgery have failed and the patient is still an active smoker at the time of surgery)
- COPD presence on patient self-report
- Diabetes mellitus (if yes, diagnosis to be confirmed via medical records or laboratory results according to 2014 Joslin Clinical Guideline for Adults with Diabetes)(Appendix 5)
- Immunosuppression
- Coronary Artery Disease
- Chronic corticosteroid use: greater than 6 months systemic use
- Serum albumin less than 3.4 g/dL
- Advanced age: 75 years or older
- Renal insufficiency, defined as serum creatinine concentration ≥2.5 mg/dL
Who cannot join
- Subject has had 4 or more previous hernia repairs (of the index hernia)
- Subject's hernia is > 350 cm2
- Complete removal of existing mesh from a prior hernia repair (in the same affected area) is not possible
- Subject has intact permanent mesh adjacent to the current hernia to be repaired
- Preperitoneal placement of mesh
- The subject is known to have a collagen disorder
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- The subject has peritonitis
- The subject is on or suspected to be placed on chemotherapy medications during any part of the study
- The subject's Body Mass Index (BMI) is > 40 kg/m2
- The subject has cirrhosis of the liver and/or ascites
- Subject is American Society of Anesthesiology Class 4 or 5
- Subject has a life expectancy of less than 2 years at the time of enrollment
- Subject has any condition that, in the opinion of the Investigator, would preclude the use of the study device, or preclude the subject from completing the follow-up requirements
- Subject has a surgical wound classified as Class II (Clean-Contaminated), Class III (Contaminated) or Class IV (Dirty-Contaminated)
- Subject has an active or latent systemic infection
- Patient has a contraindication to placement of mesh
- Subject requires surgical bridge repair as the sole repair
- Subject is pregnant or has plans to become pregnant during the study period
- Subject has enrolled in another interventional clinical study within the last 30 days
- Subject is part of the site personnel directly involved with this study
- Subject has a known allergy to the test device or component materials (patients with known allergies to tetracycline hydrochloride or kanamycin sulfate should be avoided).
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Emory University
Atlanta, Georgia, 30322
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, 70808
Overlake Hospital
Bellevue, Washington, 98004
Florida Hospital
Celebration, Florida, 34747
Georgetown Community Hospital
Georgetown, Kentucky, 40324
Hershey Penn State Medical Center
Hershey, Pennsylvania, 17033
University of Kentucky Medical Center
Lexington, Kentucky, 40536
University of Wisconsin
Madison, Wisconsin, 53792
Yale-New Haven Medical Center
New Haven, Connecticut, 06510
Methodist Hospital
Omaha, Nebraska, 68114
Legacy Emanuel Hospital
Portland, Oregon, 97210
Carilion Clinic
Roanoke, Virginia, 24013
Memorial Health University Medical Center
Savannah, Georgia, 31404
Washington University
St Louis, Missouri, 63110
Via-Christi Hospital
Wichita, Kansas, 67214
New Hanover Regional Medical Center
Wilmington, North Carolina, 28401
About this study
Official title: A Prospective, Multi-center Trial of a Long-term Bio-Absorbable Mesh With Sepra Technology in Challenging Laparoscopic Ventral or Incisional Hernia Repair
The objective of this study is to collect additional data on safety, performance and effectiveness of Phasix™ ST in subjects receiving laparoscopic ventral or incisional hernia repair at high risk for surgical site occurrence (SSO).
Read the detailed description
Subjects at high risk are defined as having 1 or more of the following co-morbid conditions: body mass index (BMI) between 30-40 kg/m2, inclusive, active smokers, chronic obstructive pulmonary disease (COPD), diabetes, immunosuppression, coronary artery disease, chronic corticosteroid use, low pre-operative serum albumin, advanced age, or renal insufficiency.
- Conditions
- Hernia, Ventral, Incisional Hernia
- Being tested
- Phasix™ ST
- Medical subject headings
- Hernia, Ventral, Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phasix™ STDevice
Phasix™ ST is a fully resorbable mesh with a hydrogel coating that is also resorbable.
| Study group | Role | What they receive |
|---|---|---|
| Phasix™ ST | Experimental | Subjects treated with Phasix™ ST mesh Receives: Device: Phasix™ ST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Occurrence Rate
Proportion of subjects with Surgical Site Occurrences(SSO), which are defined as hematoma, seroma, surgical site infection, wound dehiscence, skin necrosis and fistula requiring intervention. Occurrences at the surgical site will be assessed by physical examination at each study visit through 45 days.
Measured: 45 Days
Secondary outcomes (9)
Surgical Site Occurrence Rate
Number of subjects with Surgical Site Occurrences, which are defined as hematoma, seroma, surgical site infection, wound dehiscence, skin necrosis and fistula requiring intervention. Occurrences at the surgical site will be assessed by physical examination at each study visit through 3 months.
Measured: 3 months
Hernia Recurrence Rate
Proportion of subjects with hernia recurrence. Hernia recurrence rates will be assessed by physical examination (or if standard of care via CT/MRI or ultrasonography) at each study visit through 24 months. A recurrent hernia will be defined as any hernia identified or confirmed by the investigator, during any study follow-up visit, in approximately the same position as the hernia repaired in the study procedure.
Measured: 24 Months
Pain Visual Analog Scale
Mean change in self-reported pain measured on a Visual Analog Scale between Baseline and 24-month through follow up. Scores are measured on a 10.0 cm line, scores range from 0 to 10, higher values correspond with higher pain perception. The outcome measure is presented as the absolute difference between the pain perception at Baseline and the pain perception at 24-month follow up.
Measured: 24 Months
Device-related Adverse Event Incidence
Proportion of subjects with Investigator-determined device-related adverse events
Measured: 24 Months
Rate of Reoperation Due to Index Hernia Repair
Rate of reoperation due to the index hernia repair
Measured: 24 Months
Change in Carolinas Comfort Scale
Each scale score (sensation of mesh, pain or movement limitations) ranges from 0-5 and is the average across the domains. The Total CCS Score ranges from 0-5 and is the average of the 3 scale scores. Low scores represent fewer symptoms or difficulties.
Absolute values of the Total CCS Score at Baseline, 1-Month follow-up, at 3-Month follow-up, at 6-Month follow-up, at 12-Month follow-up, at 18-Month follow-up, and at 24-Month follow up are reported.
The absolute value at Baseline, or a change in self-reported quality of life measured by Carolinas Comfort Scale® cannot be reported, as subjects had incorrectly answered the questions on Sensation of Mesh at Baseline where no Phasix Mesh was yet implanted, thereby creating a bias in the results.
Measured: 24 Months
Change in SF(Short-form)-12
The Short Form (SF)-12 version 2 (v2) is a multi-purpose, twelve item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health and social functioning. The SF-12v2 yields scale scores for each of these seven health domains, and two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Absolute values of the PCS and MCS scores at Baseline, 1-Month follow-up, at 3-Month follow-up, at 6-Month follow-up, at 12-Month follow-up, at 18-Month follow-up, and at 24-Month follow up are reported.
Measured: 24 Months
Surgical Procedure Time as Measured From Incision to Closure
Surgical procedure time as measured from incision to closure (skin to skin)
Measured: During Procedure, up to 243 minutes
Length of Hospital Stay
Number of days admitted to the hospital for index surgery
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startApr 2016
- Primary completion15 Nov 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hernia, VentralStudies of the same condition, open and under way.
- More trials run by C. R. BardThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Hope, MD, Principal investigator, New Hanover Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712398
- Sponsor's protocol ID
- DVL-HE-017
- Acronym
- ATLAS
- Status last verified
- Dec 2020
- First submitted
- 15 Mar 2016
- Last updated
- 8 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center Trial of a Long-term Bio-Absorbable Mesh With Sepra Technology in Challenging Laparoscopic Ventral or Incisional Hernia Repair
- ClinicalTrials.gov ID
- NCT02712398
- Acronym / sponsor ID
- ATLAS / DVL-HE-017
- Conditions
- Hernia, Ventral, Incisional Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Apr 2016 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 18 Mar 2016 (estimated)
- Results
- Posted 8 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to collect additional data on safety, performance and effectiveness of Phasix™ ST in subjects receiving laparoscopic ventral or incisional hernia repair at high risk for surgical site occurrence (SSO).
Detailed description
Subjects at high risk are defined as having 1 or more of the following co-morbid conditions: body mass index (BMI) between 30-40 kg/m2, inclusive, active smokers, chronic obstructive pulmonary disease (COPD), diabetes, immunosuppression, coronary artery disease, chronic corticosteroid use, low pre-operative serum albumin, advanced age, or renal insufficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phasix™ ST | Experimental | Device: Phasix™ STSubjects treated with Phasix™ ST mesh |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Subject must be 18 years of age or older
- Subject must be willing to give written informed consent
- Subject must be diagnosed with ventral or abdominal incisional hernia
- Subject must be willing to undergo laparoscopic hernia repair using intraabdominal placement (with or without Component Separation Technique (CST))
- Surgeon must be able to fully close the hernia defect. Defect closure is defined as complete reapproximation of fascial edges, leaving no gap. Since the safety and effectiveness of Phasix™ ST Mesh in bridging repairs has not been evaluated or established, the defect should be closed prior to mesh use.
Key exclusion criteria (21 listed)
- Subject has had 4 or more previous hernia repairs (of the index hernia)
- Subject's hernia is > 350 cm2
- Complete removal of existing mesh from a prior hernia repair (in the same affected area) is not possible
- Subject has intact permanent mesh adjacent to the current hernia to be repaired
- Preperitoneal placement of mesh
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 |
|---|---|---|
| Phasix™ STPhasix™ ST is a fully resorbable mesh with a hydrogel coating that is also resorbable. | Device | Phasix™ ST |
Primary outcome
Surgical Site Occurrence Rate
Time frame: 45 Days
Proportion of subjects with Surgical Site Occurrences(SSO), which are defined as hematoma, seroma, surgical site infection, wound dehiscence, skin necrosis and fistula requiring intervention. Occurrences at the surgical site will be assessed by physical examination at each study visit through 45 days.
9 secondary outcomes
Surgical Site Occurrence Rate
Time frame: 3 months
Hernia Recurrence Rate
Time frame: 24 Months
Pain Visual Analog Scale
Time frame: 24 Months
Device-related Adverse Event Incidence
Time frame: 24 Months
Rate of Reoperation Due to Index Hernia Repair
Time frame: 24 Months
Change in Carolinas Comfort Scale
Time frame: 24 Months
Change in SF(Short-form)-12
Time frame: 24 Months
Surgical Procedure Time as Measured From Incision to Closure
Time frame: During Procedure, up to 243 minutes
Length of Hospital Stay
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
William Hope, MD principal investigator
New Hanover Regional Medical Center
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phasix™ ST in people with Hernia, Ventral and Incisional Hernia, run by C. R. Bard at 16 sites 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 17 inclusion and 21 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: finished, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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?
Yes. Results are posted in the registry (first posted 8 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Surgical Site Occurrence Rate (time frame: 45 Days). 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 8 Jan 2021.