NCT04282720

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

March 31, 2020

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2023

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

April 8, 2026

Completed
Last Updated

April 8, 2026

Status Verified

November 1, 2024

Enrollment Period

3.4 years

First QC Date

February 21, 2020

Results QC Date

November 20, 2024

Last Update Submit

March 30, 2026

Conditions

Hiatal Hernia

Outcome Measures

Primary Outcomes (1)

  • Recurrence Rate

    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.

    6 months post surgery

Secondary Outcomes (1)

  • Quality of Life Using GERD-HRQL Scale

    6 month post surgery

Study Arms (1)

SurgiMend Mesh

OTHER

SurgiMend Mesh - FDA approved noncross-linked bovine dermis biologic mesh. SurgiMend Mesh will be used according to FDA approved recommendations for the use of abdominal wall hernia reinforcement. SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. SurgiMend is specifically indicated for: Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias.

Device: SurgiMend Mesh

Interventions

SurgiMend MeshDEVICE

Following placement of SurgiMend mesh during laparoscopic hiatal hernia repair, patient will be scheduled for follow up using an upper GI series to check for recurrence of the hiatal hernia. Follow up upper GIs will be performed at 6 months post-surgery. Subjects will also complete a QOL survey to assess other GI associated symptoms before and after surgical repair. The QOL survey can be administered by phone by study team members

SurgiMend Mesh

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of type 3 or 4 hiatal hernia (8)
  • Subject is able to give informed consent
  • Adults at least 18 years of age

You may not qualify if:

  • Currently pregnant
  • Prior hiatal hernia repair
  • Prior gastric surgery
  • Prior foregut surgery
  • Known esophageal dysfunction or dysmotility
  • Cirrhosis or ascites
  • Known malignancy
  • Known allergy to biologic mesh
  • Known allergy to barium or other contrast material used in UGI
  • Religious objection to animal implant
  • Cognitive impairment
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kettering Health Network - Grandview Medical Center

Dayton, Ohio, 45405, United States

Location

Related Publications (8)

  • Furnee E, Hazebroek E. Mesh in laparoscopic large hiatal hernia repair: a systematic review of the literature. Surg Endosc. 2013 Nov;27(11):3998-4008. doi: 10.1007/s00464-013-3036-y. Epub 2013 Jun 21.

    PMID: 23793804BACKGROUND

  • Lidor AO, Steele KE, Stem M, Fleming RM, Schweitzer MA, Marohn MR. Long-term quality of life and risk factors for recurrence after laparoscopic repair of paraesophageal hernia. JAMA Surg. 2015 May;150(5):424-31. doi: 10.1001/jamasurg.2015.25.

    PMID: 25785415BACKGROUND

  • Nason KS, Luketich JD, Qureshi I, Keeley S, Trainor S, Awais O, Shende M, Landreneau RJ, Jobe BA, Pennathur A. Laparoscopic repair of giant paraesophageal hernia results in long-term patient satisfaction and a durable repair. J Gastrointest Surg. 2008 Dec;12(12):2066-75; discussion 2075-7. doi: 10.1007/s11605-008-0712-7. Epub 2008 Oct 8.

    PMID: 18841422BACKGROUND

  • Adelman DM, Selber JC, Butler CE. Bovine versus Porcine Acellular Dermal Matrix: A Comparison of Mechanical Properties. Plast Reconstr Surg Glob Open. 2014 Jun 6;2(5):e155. doi: 10.1097/GOX.0000000000000072. eCollection 2014 May.

    PMID: 25289348BACKGROUND

  • Velanovich V. The development of the GERD-HRQL symptom severity instrument. Dis Esophagus. 2007;20(2):130-4. doi: 10.1111/j.1442-2050.2007.00658.x.

    PMID: 17439596BACKGROUND

  • Radiologic Society of North America (2019). Radiation dose in X-Ray and CT Exam. Available at https://www.radiologyinfo.org/en/info.cfm?pg=safety-xray

    BACKGROUND

  • K. S. Silvipriya, K. Krishna Kumar*, A. R. Bhat, B. Dinesh Kumar, Anish John, Panayappan Lakshmanan. Collagen: Animal Sources and Biomedical Application. Journal of Applied Pharmaceutical Science Vol. 5 (03), pp. 123-127, March, 2015. DOI: 10.7324/JAPS.2015.50322

    BACKGROUND

  • Kahrilas PJ, Kim HC, Pandolfino JE. Approaches to the diagnosis and grading of hiatal hernia. Best Pract Res Clin Gastroenterol. 2008;22(4):601-16. doi: 10.1016/j.bpg.2007.12.007.

    PMID: 18656819BACKGROUND

MeSH Terms

Conditions

Hernia, Hiatal

Condition Hierarchy (Ancestors)

Hernia, DiaphragmaticInternal HerniaHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Paul Levy
Organization
Kettering Health
paul.levy@ketteringhealth.org
+1(937)531-0195

Study Officials

  • Paul Levy, DO

    Kettering Health Network

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2020

First Posted

February 25, 2020

Study Start

March 31, 2020

Primary Completion

August 16, 2023

Study Completion

September 5, 2023

Last Updated

April 8, 2026

Results First Posted

April 8, 2026

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)