An interventional study of Phasix™ Mesh in Hernia, Hernia, Abdominal and Hernia, Incisional, sponsored by C. R. Bard. Completed at 15 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-25.
Sponsored by C. R. Bard (part of Becton, Dickinson and Company) · Not applicable, Interventional, and Treatment
Among 21 studies in Hernia with a site in Belgium — 3 open to participants now, 4 under way, none of them phase 3. Hernia · Belgium.
Among the 21 studies in Hernia with a site in Belgium, this one is one of 3 that started in 2016, is one of 5 with no phase, and was the 12th registered.
257 studies on the registry are indexed under Hernia; 37 are open to participants now.
This study's enrollment of 84 is close to the median of 80 across 167 interventional studies indexed under Hernia.
Browse Hernia studies →3 of the 21 studies in Hernia with a site in Belgium are open now, in 1 country. Each count lists the studies.
Of the 24 Hernia studies recruiting now, 17 (71%) set no upper age limit and 2 (8%) stop at 75 or younger; 4 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →21 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 3 started in 2016.
Median enrollment 132 across the 8 interventional studies, 115 across the 13 observational. Of the 16 that completed or were terminated, 5 (31%) have results posted.
12 of 21 have an industry lead sponsor. The 10 most frequent:
C. R. Bard is the lead sponsor of 117 studies on the registry; 6 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 13 (76%) have results posted.
C. R. Bard has 5 studies filed under Hernia — fewer than ten, so there is no comparison to draw.
1 of the studies in Hernia with a site in Belgium that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02781870Algemeen Ziekenhuis Maria MiddelaresLaparoscopic Groin Hernia Repair by a 3D ENDOLAP Visible Mesh With or Without LiquiBand Fix 8 Mesh Fixation | 2026-12 |
Among the 21 studies in Hernia with a site in Belgium, from their registry updates:
Nothing recorded among them since 2026-09-25.
The purpose of this study is to collect additional data on safety and performance of Phasix™ Mesh in subjects requiring Ventral Hernia Working Group (VHWG) Grade 3 midline hernia repair.
Approximately 85 subjects, at approximately 12 sites across Europe will be enrolled and treated to study the use of Phasix™ Mesh. All treated subjects will be followed for 2 years post-implantation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients treated with Phasix™ Mesh for hernia repair
Device: Phasix™ Mesh
A resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB)
Number of Participants With One or More Surgical Site Occurrence Within 3 Months of Index Procedure
Proportions 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. For analysis purposes, the aggregate Surgical Site Occurrence is defined as follows: "The question \<Is there any evidence of surgical site occurrence (SSO) in the same location as the index procedure?\> is answered with \<yes\>
Time frame: 3 Months
Number of Participants With One or More Surgical Site Occurrence Within 24 Months of Index Procedure
Proportions 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. For analysis purposes, the aggregate Surgical Site Occurrence is defined as follows: "The question \<Is there any evidence of surgical site occurrence (SSO) in the same location as the index procedure?\> is answered with \<yes\> "
Time frame: 24 Months
Number of Participants With a Hernia Recurrence
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.
Time frame: 24 Months
Number of Participants With One or More Surgical Site Infection
Proportion of subjects with surgical site infections. Infections at the surgical site will be assessed by physical examination at each study visit through 24 months. If an infection is suspected, a routine culture, obtained via each site's standard protocol, should be obtained to determine cell count and type (i.e. yeast, gram positive or gram negative bacteria, or other). If genus and species of the culture are identified as part of the routine practice at the site, that information should be recorded. Classification will follow the US Centers of Disease Control and Prevention (CDC) guidelines for superficial, deep and organ/space surgical site infections.
Time frame: 24 Months
Mean Change in Pain Between Baseline (Pre-Index Procedure) and 24 Months Post-Index Procedure, as Measured by a 10.0 cm Visual Analogue Scale
Mean change in self-reported pain measured on a Visual Analog Scale between Baseline and 24-month follow up. Scores are measured on a 10.0 cm line, lower values correspond with low 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. A negative score means a decrease in pain perception.
Time frame: 24 Months
Number of Participants With One or More Device-related Adverse Event
Incidence Device-related Adverse Events: number of subjects with one or more possibly or definitely device-related Adverse Event.
Time frame: 24 Months
Number of Participants Requiring Reoperation Due to Index Hernia Repair
Rate of reoperation due to the index hernia repair: the proportion of subjects with post-procedure reoperation due to the index hernia repair.
Time frame: 24 Months
Mean Patient Reported Outcomes on Quality of Life Parameters as Measured by the Carolinas Comfort Scale (CCS) at 1, 3, 12 and 24 Months Post-Index Procedure
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 1-Month follow-up, at 3-Month follow-up, at 12-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.
Time frame: 24 Months
Mean Change in Quality of Life Assessments as Measured by the EQ-5D Between Baseline (Pre-Index Procedure) and 24 Months Post-Index Procedure
Change in self-reported quality of life measured by EuroQol-5 Dimensions (EQ-5D™). Each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) has 3 levels (no problems, some problems and extreme problems). The data is converted into a summary index number between 0 and 1, whereby 1 corresponds with the highest perception of Quality of Life. The outcome measure reports the absolute change from Baseline until 24-months follow up. A positive value corresponds with an increase in Quality of Life.
Time frame: 24 Months
Mean Surgical Procedure Time of the Index Procedure as Measured From Incision to Closure
Surgical procedure time as measured from incision to closure (skin to skin)
Time frame: 1 day
Mean Time Until Participants Were Able to Return to Work
The number of days until subject returned to work, calculated as the date when employed subjects were able to fully get back to work minus the date of surgery.
Time frame: 24 Months
Mean Length of Hospital Stay Related to Index Procedure
The length of hospital stay for the index procedure is calculated as the date of hospital discharge minus the date of hospital admission. Days in intensive care unit, days in step down unit (medium care) and days in the ward will be summarized as well.
Time frame: 1 Month
Study subjects were enrolled between 22-Mar-2016 and 26-Apr-2017 at 15 different sites in 8 European countries.
| Milestone | Phasix™ Mesh |
|---|---|
| Started | 84 |
| Completed | 69 |
| Not completed | 15 |
| Withdrew: Death | 3 |
| Withdrew: Lost to follow-up | 4 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Physician decision | 3 |
| Withdrew: Phasix mesh explanted | 1 |
| Withdrew: Unable due to non-study-related illness | 3 |
Proportions 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. For analysis purposes, the aggregate Surgical Site Occurrence is defined as follows: "The question \<Is there any evidence of surgical site occurrence (SSO) in the same location as the index procedure?\> is answered with \<yes\>
| Participants | Phasix™ Mesh |
|---|---|
| Number of Participants With One or More Surgical Site Occurrence Within 3 Months of Index Procedure | 22 |
Proportions 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. For analysis purposes, the aggregate Surgical Site Occurrence is defined as follows: "The question \<Is there any evidence of surgical site occurrence (SSO) in the same location as the index procedure?\> is answered with \<yes\> "
| Participants | Phasix™ Mesh |
|---|---|
| Number of Participants With One or More Surgical Site Occurrence Within 24 Months of Index Procedure | 22 |
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.
| Participants | Phasix™ Mesh |
|---|---|
| Number of Participants With a Hernia Recurrence | 8 |
Proportion of subjects with surgical site infections. Infections at the surgical site will be assessed by physical examination at each study visit through 24 months. If an infection is suspected, a routine culture, obtained via each site's standard protocol, should be obtained to determine cell count and type (i.e. yeast, gram positive or gram negative bacteria, or other). If genus and species of the culture are identified as part of the routine practice at the site, that information should be recorded. Classification will follow the US Centers of Disease Control and Prevention (CDC) guidelines for superficial, deep and organ/space surgical site infections.
| Participants | Phasix™ Mesh |
|---|---|
| Number of Participants With One or More Surgical Site Infection | 12 |
Mean change in self-reported pain measured on a Visual Analog Scale between Baseline and 24-month follow up. Scores are measured on a 10.0 cm line, lower values correspond with low 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. A negative score means a decrease in pain perception.
| score on a scale | Phasix™ Mesh |
|---|---|
| Mean Change in Pain Between Baseline (Pre-Index Procedure) and 24 Months Post-Index Procedure, as Measured by a 10.0 cm Visual Analogue Scale | -0.7 ± 2.45 |
Incidence Device-related Adverse Events: number of subjects with one or more possibly or definitely device-related Adverse Event.
| Participants | Phasix™ Mesh |
|---|---|
| Number of Participants With One or More Device-related Adverse Event | 16 |
Rate of reoperation due to the index hernia repair: the proportion of subjects with post-procedure reoperation due to the index hernia repair.
| Participants | Phasix™ Mesh |
|---|---|
| Number of Participants Requiring Reoperation Due to Index Hernia Repair | 13 |
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 1-Month follow-up, at 3-Month follow-up, at 12-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.
| score on a scale | Phasix™ Mesh |
|---|---|
| Total CCS Score at 1-Month | 0.6 ± 0.8 |
| Total CCS Score at 3-Months | 0.5 ± 0.84 |
| Total CCS Score at 12-Months | 0.3 ± 0.62 |
| Total CCS Score at 24-Months | 0.3 ± 0.66 |
Change in self-reported quality of life measured by EuroQol-5 Dimensions (EQ-5D™). Each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) has 3 levels (no problems, some problems and extreme problems). The data is converted into a summary index number between 0 and 1, whereby 1 corresponds with the highest perception of Quality of Life. The outcome measure reports the absolute change from Baseline until 24-months follow up. A positive value corresponds with an increase in Quality of Life.
| score on a scale | Phasix™ Mesh |
|---|---|
| Mean Change in Quality of Life Assessments as Measured by the EQ-5D Between Baseline (Pre-Index Procedure) and 24 Months Post-Index Procedure | 0.11 ± 0.22 |
Surgical procedure time as measured from incision to closure (skin to skin)
| minutes | Phasix™ Mesh |
|---|---|
| Mean Surgical Procedure Time of the Index Procedure as Measured From Incision to Closure | 198 ± 110.86 |
The number of days until subject returned to work, calculated as the date when employed subjects were able to fully get back to work minus the date of surgery.
| days | Phasix™ Mesh |
|---|---|
| Mean Time Until Participants Were Able to Return to Work | 101.3 ± 160.38 |
The length of hospital stay for the index procedure is calculated as the date of hospital discharge minus the date of hospital admission. Days in intensive care unit, days in step down unit (medium care) and days in the ward will be summarized as well.
| days | Phasix™ Mesh |
|---|---|
| Total Length of Hospital Stay | 10.9 ± 7.61 |
| Days in Intensive Care Unit | 1.0 ± 3.16 |
| Days in Step Down (medium care) unit | 0.3 ± 2.18 |
| Days in the Ward | 9.5 ± 5.87 |
Collected over 24 months. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phasix™ Mesh | 3/84 (3.6%) | 40/84 (47.6%) | 35/84 (41.7%) |
| Event | Phasix™ Mesh |
|---|---|
| Incisional HerniaInjury, poisoning and procedural complications | 5/84 |
| Stomal HerniaInjury, poisoning and procedural complications | 4/84 |
| Abdominal Wall AbscessInfections and infestations | 3/84 |
| Device Related InfectionInfections and infestations | 2/84 |
| Post Procedural PneumoniaInfections and infestations | 2/84 |
| Postoperative Wound InfectionInfections and infestations | 2/84 |
| IleusGastrointestinal disorders | 2/84 |
| Hip FractureInjury, poisoning and procedural complications | 2/84 |
| Wound DehiscenceInjury, poisoning and procedural complications | 2/84 |
| Chronic Obstructive Pulmonary DiseaseRespiratory, thoracic and mediastinal disorders | 2/84 |
| Event | Phasix™ Mesh |
|---|---|
| SeromaInjury, poisoning and procedural complications | 15/84 |
| Postoperative Wound InfectionInfections and infestations | 10/84 |
| Wound DehiscenceInjury, poisoning and procedural complications | 10/84 |
| Stomal HerniaInjury, poisoning and procedural complications | 5/84 |
| Incisional HerniaInjury, poisoning and procedural complications | 4/84 |
| Subcutaneous HaematomaInjury, poisoning and procedural complications | 3/84 |
| Abdominal PainGastrointestinal disorders | 2/84 |
| Abdominal Wall HaematomaGastrointestinal disorders | 2/84 |
| Skin NecrosisSkin and subcutaneous tissue disorders | 2/84 |
| Age, Continuous(years) | Phasix™ Mesh |
|---|---|
| Mean | 62.5 ± 12.41 |
| Sex: Female, Male(Participants) | Phasix™ Mesh |
|---|---|
| Female | 33 |
| Male | 51 |
| Race (NIH/OMB)(Participants) | Phasix™ Mesh |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 72 |
| More than one race | 0 |
| Unknown or Not Reported | 11 |
| Region of Enrollment(participants) | Phasix™ Mesh |
|---|---|
| Austria | 3 |
| Netherlands | 14 |
| Belgium | 25 |
| Denmark | 10 |
| Italy | 3 |
| United Kingdom | 6 |
| France | 11 |
| Germany | 12 |
| BMI(kg/m^2) | Phasix™ Mesh |
|---|---|
| Mean | 27.8 ± 4.03 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2016 to primary completion in Jul 2017, 16 months.
Results were first posted in Jun 2020, 2 years 10 months after primary completion.
Of 57 interventional studies with no phase under Hernia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 64. This study's 16 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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