Trials / Terminated
TerminatedNCT03280121
Hernia Reduction Prior to Scheduled TIF Completion
Hernia Reduction Prior to Scheduled TIF Completion- The HEURISTIC Study
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- EndoGastric Solutions · Industry
- Sex
- All
- Age
- 18 Years – 72 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | EsophyX ZR transoral device | TIF |
Timeline
- Start date
- 2018-10-05
- Primary completion
- 2020-04-30
- Completion
- 2020-10-26
- First posted
- 2017-09-12
- Last updated
- 2021-02-10
- Results posted
- 2021-01-07
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03280121. Inclusion in this directory is not an endorsement.