Back to results

Hernia Reduction Prior to Scheduled TIF Completion (HEURISTIC)

Primary Purpose

Fundoplication

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

EsophyX ZR transoral device

About this trial

This is an interventional treatment trial for Fundoplication focused on measuring transoral incisionless

Eligibility Criteria

18 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18-72 years
Dependent upon daily PPIs for > 6 months. Daily use is defined as a double dose, or full dose or half dose taken daily for more than 80% of the total number of days during the proceeding evaluation period
Troublesome symptoms, specifically heartburn or regurgitation, while on optimized dose of PPI's Troublesome heartburn or regurgitation symptoms are those which occur a minimum of 2 days a week and are mild to severe in severity
Abnormal ambulatory (Bravo) pH study after off PPI therapy for 7 days, i.e. > 5.3% of the time with pH < 4 in a 48-hour monitoring period
Normal or near normal esophageal motility (by Upper GI/ esophagram or manometry as required)
Pre-enrollment Hiatal Hernia (axial height and transverse dimension) from > 2 cm up to 4 cm inclusive.
Patient willing to cooperate with post-operative dietary recommendations and assessment tests at the requisite follow-up visits
Signed informed consent Exclusion Criteria

1. BMI > 35 2. Hiatal hernia ≤ 2 and > 4 cm 3. Esophagitis Los Angeles grade C or D 4. Esophageal ulcer 5. Esophageal stricture 6. Long-segment Barretts esophagus (Prague: C > 1, M > 3) 7. Esophageal motility disorder 8. Pregnancy or plans for pregnancy in the next 12 months (in females) 9. Immunosuppression 10. ASA > 2 11. Portal hypertension and/or varices 12. History of previous resective gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis 13. Active gastro-duodenal ulcer disease 14. Gastric outlet obstruction or stenosis 15. Severe gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study if patient complains of postprandial satiety during assessment 16. Coagulation disorders 17. Atypical symptoms including gas bloat and dysphagia. 18. Any other presenting condition that in the opinion of the investigator would not make participation in this study in the patient's best interest.

Post Enrollment Exclusion -

1. Inability to repair Hiatal hernia with at least 2cm of intra-abdominal esophagus length.

Sites / Locations

Elkhart General Hospital
Aspirus Iron River Hospital
Northern Nevada Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TIF using EsophyX ZR transoral device

Arm Description

Transoral incisionless fundoplication which is a minimally invasive treatment for gastroesophageal reflux disease (GERD) using EsophyX ZR transoral device

Outcomes

Primary Outcome Measures

pH Study

Number of Participants with Normalization of Esophageal Acid Exposure. Normalization in esophageal acid exposure is defined by ≤ 5.3% of total time pH < 4 in

Secondary Outcome Measures

Number of Participants With a Change in Troublesome Symptoms From Baseline

Per Montreal Consensus definition, troublesome symptoms are mild symptoms occurring two (2) or more days per week, or moderate/severe symptoms occurring more than 1 day per week

Number of Participants With a Change in PPI Consumption From Baseline to 6 Months

from daily use to occasional use or none at all.

Full Information

NCT ID

NCT03280121

First Posted

September 9, 2017

Last Updated

January 25, 2021

Sponsor

EndoGastric Solutions

1. Study Identification

Unique Protocol Identification Number

NCT03280121

Brief Title

Hernia Reduction Prior to Scheduled TIF Completion

Acronym

HEURISTIC

Official Title

Hernia Reduction Prior to Scheduled TIF Completion- The HEURISTIC Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Terminated

Why Stopped

Slow enrollment and Covid-19

Study Start Date

October 5, 2018 (Actual)

Primary Completion Date

April 30, 2020 (Actual)

Study Completion Date

October 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EndoGastric Solutions

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Hernia Reduction Prior to Scheduled TIF Completion using EsophyX ZR transoral device

Detailed Description

Evaluation of the relative merits, safety and effectiveness of the EsophyX ZR transoral device in performing the standardized TIF 2.0 procedure preceded by laparoscopic Hiatal Hernia repair in PPI-prescribed patients with persistent "troublesome symptoms" per the Montreal consensus definition

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fundoplication

Keywords

transoral incisionless

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Prospective, investigator initiated, multicenter, non-randomized single arm, open label.

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TIF using EsophyX ZR transoral device

Arm Type

Experimental

Arm Description

Transoral incisionless fundoplication which is a minimally invasive treatment for gastroesophageal reflux disease (GERD) using EsophyX ZR transoral device

Intervention Type

Device

Intervention Name(s)

EsophyX ZR transoral device

Intervention Description

TIF

Primary Outcome Measure Information:

Title

pH Study

Description

Number of Participants with Normalization of Esophageal Acid Exposure. Normalization in esophageal acid exposure is defined by ≤ 5.3% of total time pH < 4 in

Time Frame

48 hour monitoring period

Secondary Outcome Measure Information:

Title

Number of Participants With a Change in Troublesome Symptoms From Baseline

Description

Per Montreal Consensus definition, troublesome symptoms are mild symptoms occurring two (2) or more days per week, or moderate/severe symptoms occurring more than 1 day per week

Time Frame

6 months

Title

Number of Participants With a Change in PPI Consumption From Baseline to 6 Months

Description

from daily use to occasional use or none at all.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

72 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18-72 years Dependent upon daily PPIs for > 6 months. Daily use is defined as a double dose, or full dose or half dose taken daily for more than 80% of the total number of days during the proceeding evaluation period Troublesome symptoms, specifically heartburn or regurgitation, while on optimized dose of PPI's Troublesome heartburn or regurgitation symptoms are those which occur a minimum of 2 days a week and are mild to severe in severity Abnormal ambulatory (Bravo) pH study after off PPI therapy for 7 days, i.e. > 5.3% of the time with pH < 4 in a 48-hour monitoring period Normal or near normal esophageal motility (by Upper GI/ esophagram or manometry as required) Pre-enrollment Hiatal Hernia (axial height and transverse dimension) from > 2 cm up to 4 cm inclusive. Patient willing to cooperate with post-operative dietary recommendations and assessment tests at the requisite follow-up visits Signed informed consent Exclusion Criteria 1. BMI > 35 2. Hiatal hernia ≤ 2 and > 4 cm 3. Esophagitis Los Angeles grade C or D 4. Esophageal ulcer 5. Esophageal stricture 6. Long-segment Barretts esophagus (Prague: C > 1, M > 3) 7. Esophageal motility disorder 8. Pregnancy or plans for pregnancy in the next 12 months (in females) 9. Immunosuppression 10. ASA > 2 11. Portal hypertension and/or varices 12. History of previous resective gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis 13. Active gastro-duodenal ulcer disease 14. Gastric outlet obstruction or stenosis 15. Severe gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study if patient complains of postprandial satiety during assessment 16. Coagulation disorders 17. Atypical symptoms including gas bloat and dysphagia. 18. Any other presenting condition that in the opinion of the investigator would not make participation in this study in the patient's best interest. Post Enrollment Exclusion - 1. Inability to repair Hiatal hernia with at least 2cm of intra-abdominal esophagus length.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Murray, MD,FACS

Organizational Affiliation

Northern Nevada Medical Group

Official's Role

Principal Investigator

Facility Information:

Facility Name

Elkhart General Hospital

City

Elkhart

State/Province

Indiana

ZIP/Postal Code

46514

Country

United States

Facility Name

Aspirus Iron River Hospital

City

Iron River

State/Province

Michigan

ZIP/Postal Code

49935

Country

United States

Facility Name

Northern Nevada Medical Center

City

Sparks

State/Province

Nevada

ZIP/Postal Code

89434

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Hernia Reduction Prior to Scheduled TIF Completion

We'll reach out to this number within 24 hrs