Trial Outcomes & Findings for SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support in Ventral Hernia Repair (NCT NCT01981044)

NCT ID: NCT01981044

Last Updated: 2022-08-26

Results Overview

Hernia recurrence at 6 months post-operatively will be assessed by the Investigator and then confirmed via an independent physician.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 1 participants
• Primary outcome timeframe: 6 months postoperatively
• Results posted on: 2022-08-26

Participant Flow

Participant milestones

Measure	SERI® Surgical Scaffold It is a prospective, multicenter, single-arm, post-market on-label clinical study of a 510(k)-cleared device. Silk surgical mesh: A CE Marked, 510(k) cleared, knitted, multi-filament, bioengineered, silk mesh indicated for use as a transitory scaffold for soft tissue support and repair
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support in Ventral Hernia Repair

Baseline characteristics by cohort

Measure	SERI® Surgical Scaffold n=1 Participants It is a prospective, multicenter, single-arm, post-market on-label clinical study of a 510(k)-cleared device. Silk surgical mesh: A CE Marked, 510(k) cleared, knitted, multi-filament, bioengineered, silk mesh indicated for use as a transitory scaffold for soft tissue support and repair
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months postoperatively

Population: Adults between 18 and 70 years of age with SERI for ventral hernia repair

Hernia recurrence at 6 months post-operatively will be assessed by the Investigator and then confirmed via an independent physician.

Outcome measures

Measure	SERI® Surgical Scaffold n=1 Participants It is a prospective, multicenter, single-arm, post-market on-label clinical study of a 510(k)-cleared device. Silk surgical mesh: A CE Marked, 510(k) cleared, knitted, multi-filament, bioengineered, silk mesh indicated for use as a transitory scaffold for soft tissue support and repair
Rate of Hernia Recurrence Intact primary hernia repair with SERI	1 Participants
Rate of Hernia Recurrence Hernia reoccurred	0 Participants

PRIMARY outcome

Timeframe: 12 months postoperatively

Population: Adults between 18 and 70 years of age using SERI for ventral hernia repair

Hernia recurrence at 12 months post-operatively will be assessed by the Investigator and then confirmed via an independent physician.

Outcome measures

Measure	SERI® Surgical Scaffold n=1 Participants It is a prospective, multicenter, single-arm, post-market on-label clinical study of a 510(k)-cleared device. Silk surgical mesh: A CE Marked, 510(k) cleared, knitted, multi-filament, bioengineered, silk mesh indicated for use as a transitory scaffold for soft tissue support and repair
Rate of Hernia Recurrence Intact primary hernia repair	1 Participants
Rate of Hernia Recurrence Hernia reoccurred	0 Participants

PRIMARY outcome

Timeframe: 24 months postoperatively

Population: Adults between 18 and 70 years of age with SERI for ventral hernia repair

Hernia recurrence at 24 months post-operatively will be assessed by the Investigator and then confirmed via an independent physician.

Outcome measures

Measure	SERI® Surgical Scaffold n=1 Participants It is a prospective, multicenter, single-arm, post-market on-label clinical study of a 510(k)-cleared device. Silk surgical mesh: A CE Marked, 510(k) cleared, knitted, multi-filament, bioengineered, silk mesh indicated for use as a transitory scaffold for soft tissue support and repair
Rate of Hernia Recurrence Hernia reoccurrence	0 Participants
Rate of Hernia Recurrence Intact primary repair with SERI	1 Participants

Adverse Events

SERI® Surgical Scaffold

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	SERI® Surgical Scaffold n=1 participants at risk It is a prospective, multicenter, single-arm, post-market on-label clinical study of a 510(k)-cleared device. Silk surgical mesh: A CE Marked, 510(k) cleared, knitted, multi-filament, bioengineered, silk mesh indicated for use as a transitory scaffold for soft tissue support and repair
Skin and subcutaneous tissue disorders Abcess	100.0% 1/1 • Number of events 4 • 24 months after the ventral hernia repair procedure AE definitions consistent with clinicaltrials.gov Throughout the course of the study, AEs will be monitored and reported in an AE eCRF, including seriousness, severity, relationship to device, and action taken. If AEs occur, the first concern will be the safety of the study participants. The Investigator and the research staff will monitor each subject closely, and, should a complication occur, they will use their medical judgment to do whatever is necessary to treat the problem.
Skin and subcutaneous tissue disorders Fluid Collection	100.0% 1/1 • Number of events 1 • 24 months after the ventral hernia repair procedure AE definitions consistent with clinicaltrials.gov Throughout the course of the study, AEs will be monitored and reported in an AE eCRF, including seriousness, severity, relationship to device, and action taken. If AEs occur, the first concern will be the safety of the study participants. The Investigator and the research staff will monitor each subject closely, and, should a complication occur, they will use their medical judgment to do whatever is necessary to treat the problem.

Other adverse events

Measure	SERI® Surgical Scaffold n=1 participants at risk It is a prospective, multicenter, single-arm, post-market on-label clinical study of a 510(k)-cleared device. Silk surgical mesh: A CE Marked, 510(k) cleared, knitted, multi-filament, bioengineered, silk mesh indicated for use as a transitory scaffold for soft tissue support and repair
Skin and subcutaneous tissue disorders Pain	100.0% 1/1 • Number of events 3 • 24 months after the ventral hernia repair procedure AE definitions consistent with clinicaltrials.gov Throughout the course of the study, AEs will be monitored and reported in an AE eCRF, including seriousness, severity, relationship to device, and action taken. If AEs occur, the first concern will be the safety of the study participants. The Investigator and the research staff will monitor each subject closely, and, should a complication occur, they will use their medical judgment to do whatever is necessary to treat the problem.
Skin and subcutaneous tissue disorders Abdominal Muscle Spasm	100.0% 1/1 • Number of events 1 • 24 months after the ventral hernia repair procedure AE definitions consistent with clinicaltrials.gov Throughout the course of the study, AEs will be monitored and reported in an AE eCRF, including seriousness, severity, relationship to device, and action taken. If AEs occur, the first concern will be the safety of the study participants. The Investigator and the research staff will monitor each subject closely, and, should a complication occur, they will use their medical judgment to do whatever is necessary to treat the problem.

Additional Information

Marcio Torre, M.D., M.A., Medical Monitor

Allergan Medical

Phone: 805-683-6761

Email: torre_marcio@allergan.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place