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NCT00346905
Endoscopic Implantation of Enteryx for the Treatment of Gastroesophageal Reflux Disease (GERD): Post Market Study
NA trial testing Enteryx in Gastroesophageal Reflux in 16 participants. Completed in 1 February 2008.
1 February 2008
Quick facts
| Lead sponsor | Beth Israel Deaconess Medical Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 1 October 2003 |
| Primary completion | 1 February 2008 |
| Estimated completion | 1 February 2008 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Enteryx — full drug profile →
Conditions studied
- Gastroesophageal Reflux — all drugs for Gastroesophageal Reflux →
Sponsor
Beth Israel Deaconess Medical Center
Who can join
Eligibility, any sex, with Gastroesophageal Reflux. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Clinically Significant Reduction of PPI Usage at 12, 24, and 36 Month Follow-ups Compared to Baseline in Both Singly Treated and Retreated Patients.
Time frame: 3 years either baseline to 12m, baseline to 24m, baseline to 36m
Clinically significant reduction of PPI usage is defined as either elimination of medication use or reduction in dosage of ≥50% as compared to baseline. The criterion for success is defined as more than half of patients demonstrating this degree of medication reduction.
Sponsor's own description
The study objective is to assess the long term safety and effectiveness of Enteryx device in commercial use. The long-term effects beyond one year of treatment with Enteryx have not been established.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00346905
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Gastroesophageal Reflux
Currently open trials in the same condition.
- NCT07291700 — Study on Hydrotalcite for Relief of Acid Symptoms Due to Acid Rebound After Stopping Long-Term PPI Therapy · recruiting
- NCT06255886 — Treatment of Gastroesophageal Reflux Disease in Infants · Phase 4 · recruiting
- NCT06534359 — Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia · NA · recruiting
- NCT06687603 — Multi-Site Detection of Barrett's Esophagus in Patients Without Chronic GERD Symptoms · NA · recruiting
- NCT06339801 — Role of Mucosal Impedance Measurement for the Diagnosis of Gastroesophageal Reflux Disease · recruiting
Other Beth Israel Deaconess Medical Center trials
Trials by the same sponsor.
- NCT07352657 — Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices: The RAPTOR-CIED Study (Main Phase) · NA · not yet recruiting
- NCT07531602 — Effect of PEEP on Cardiac Function · NA · not yet recruiting
- NCT07534683 — Primed to Thrive: Investigating the Combined Impact of Mindfulness Education and Meditation Practice on Psychological an · NA · not yet recruiting
- NCT07277244 — Low-Intensity Mechanical Ventilation in the Operating Room: a Pilot Study · NA · enrolling by invitation
- NCT06896474 — SDM POSSIBLE: A Breast Cancer Treatment Decision Aid for Women 70+ With Low-Risk Stage I Breast Cancers · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00346905 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Beth Israel Deaconess Medical Center
- Last refreshed: 22 June 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00346905.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing