NCT04282720

SurgiMend Mesh at the Hiatus

Completed NA Results posted Last updated 8 April 2026

What this trial tests

NA trial testing SurgiMend Mesh in Hiatal Hernia in 9 participants. Completed in 5 September 2023.

Timeline

31 March 2020

Primary endpoint
16 August 2023

5 September 2023

Quick facts

Lead sponsor	Kettering Health Network
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	9
Start date	31 March 2020
Primary completion	16 August 2023
Estimated completion	5 September 2023
Sites	1 location across United States

Drugs / interventions tested

• SurgiMend Mesh

Conditions studied

• Hiatal Hernia — all drugs for Hiatal Hernia →

Sponsor

Kettering Health Network

Who can join

18 and older, any sex, with Hiatal Hernia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Recurrence Rate Primary · 6 months post surgery

Recurrence rate will be analyzed by a Upper gastrointestinal tract radiography (UGI) and clinical evaluation in conjunction with patient's reported physiological assessment per the GERD-HRQL.

No recurrence of hernia

Group	Value	95% CI
SurgiMend Mesh	6

recurrence of hernia

Group	Value	95% CI
SurgiMend Mesh	3

Quality of Life Using GERD-HRQL Scale Secondary · 6 month post surgery

GERD-HRQL was developed to measure the typical symptoms of GERD and the effect on a patient's quality of life. Scale is 0-5 with 0 being no symptoms and 5 being symptoms are incapacitating. Total score is calculated by summing the individual scores to questions 1-15 with greatest possible score (worst symptoms) = 75 and lowest possible score (no symptoms) = 0. The total score is made up of two sub scores which addressed heartburn and regurgitation symptoms and are reported separately in a heartburn score and regurgitation score as well as the total GERD-HRQL score. The follow up scores were co

Heartburn Score

Group	Value	95% CI
Pre-hernia Repair Score	15.67	± 8.775
Post-hernia Repair Score	7.37	± 9.086

Regurgitation Score

Group	Value	95% CI
Pre-hernia Repair Score	15.44	± 7.715
Post-hernia Repair Score	6.38	± 9.349

Total Score

Group	Value	95% CI
Pre-hernia Repair Score	35.44	± 18.035
Post-hernia Repair Score	17.38	± 22.564

Sponsor's own description

Prospective, single-arm, open-label study to evaluate re-occurrence and quality of life in subjects undergoing primary Hiatal hernia repair using SurgiMend biological mesh. Up to 15, with a target of 10, subjects are planned to be enrolled at one site. All subjects will receive the SurgiMend mesh during surgery. Data collected will be compared to historical data.

Subjects will complete a pre-operative visit. After surgery, in addition to any standard of care visits, subjects will complete 3- and 6-month follow-ups involving a phone QOL survey and will have an upper GI series at 6 months.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.