Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT01982968
Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of idiopathic pulmonary fibrosis
* Abnormal GER on 24-hour pH monitoring (DeMeester score \> 14.7)
* Able to provide informed consent
* Willing to undergo laparoscopic anti-reflux surgery
Exclusion Criteria:
* FVC \< 50% predicted
* FEV1/FVC ratio \< 0.65
* Resting room air PaO2 \< 60mm Hg
* Unable to walk 50 meters on 6 minute walk test
* Acute respiratory illness in last 12 weeks
* Experimental medication for IPF in last 28 days
* Listed for lung transplantation at screening
* Unable to safely undergo surgery
* History of esophageal / bariatric / gastric surgery
* History of cancer (other than non-melanoma skin cancer) in last 3 years
* Pregnant at time of screening or enrollment
* Unable to obtain pre-authorized approval from a third party payer for surgery and related costs
* Life expectancy \< 48 weeks due to another illness
* BMI \> 35
* Known severe pulmonary hypertension (mean pressure \> 35 mm Jg on RHC; RVSP \> 50 mm Hg on ECHO)
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01982968
Study Brief:
Protocol Section:
NCT01982968