Trial Outcomes & Findings for Endoscopic Implantation of Enteryx for the Treatment of GERD (NCT NCT00346905)
NCT ID: NCT00346905
Last Updated: 2017-07-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
3 years either baseline to 12m, baseline to 24m, baseline to 36m
Results posted on
2017-07-21
Participant Flow
Referral patients experiencing moderate to severe GERD
Those not meeting inclusion/exclustion criteria were not included
Participant milestones
| Measure |
Group 1
Patients that are GERD responsive and requiring daily PPI therapy
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Endoscopic Implantation of Enteryx for the Treatment of GERD
Baseline characteristics by cohort
| Measure |
Group 1
n=16 Participants
Patients experiencing moderate GERD
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 years either baseline to 12m, baseline to 24m, baseline to 36mPopulation: Overall Number of Participants Analyzed (16) will differ at 12m, 24m, and 36m intervals due to patients who were available at the given follow-up interval.
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.
Outcome measures
| Measure |
Enteryx Treatment
n=16 Participants
Those receiving Enteryx treatment
Enteryx
|
|---|---|
|
Clinically Significant Reduction of PPI Usage at 12, 24, and 36 Month Follow-ups Compared to Baseline in Both Singly Treated and Retreated Patients.
clinically significant reduction of PPI usage 12m
|
56.25 % of Participants
|
|
Clinically Significant Reduction of PPI Usage at 12, 24, and 36 Month Follow-ups Compared to Baseline in Both Singly Treated and Retreated Patients.
clinically significant reduction of PPI usage 24m
|
45.45 % of Participants
|
|
Clinically Significant Reduction of PPI Usage at 12, 24, and 36 Month Follow-ups Compared to Baseline in Both Singly Treated and Retreated Patients.
clinically significant reduction of PPI usage 36m
|
50.00 % of Participants
|
Adverse Events
Group 1 - Single Arm
Serious events: 10 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 - Single Arm
n=16 participants at risk
Those experiencing GERD
|
|---|---|
|
Cardiac disorders
Flutter Fibrillation
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Throat Cancer
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
12.5%
2/16 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
General disorders
Retrosternal Chest Pain
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Cardiac disorders
Severe Chest Pain / Myocardial Infarction
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Nodule in Thyroid
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Infections and infestations
Chemical Mediastinitis
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Chest Pain with Inspiration
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Torn Rotator Cuff
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Surgical and medical procedures
Hiatal Hernia Repair
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Nissen Fundoplication for Severe GERD
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Bleeding Esophageal Ulcer
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Cardiac disorders
Chest Pain secondary to Coronary Artery Disease
|
6.2%
1/16 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
Esophagitis
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Gastritis
|
6.2%
1/16 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
General disorders
Rigors "Shaking Chills"
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Infections and infestations
C-Diff Colitis
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Cardiac disorders
Heart Attack
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Surgical and medical procedures
Nissen Fundoplication Repair with Hospital Stay for GERD and Pulmonary Symptoms
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Surgical and medical procedures
Nissen Fundoplication for GERD. Hospitalized for 2 days post surgery.
|
6.2%
1/16 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
Group 1 - Single Arm
n=16 participants at risk
Those experiencing GERD
|
|---|---|
|
Gastrointestinal disorders
Worse Than Ever Heartburn. Woke Pt. from Sleep.
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Herniated Cervical Disc
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Dysphagia
|
37.5%
6/16 • Number of events 7 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthritic low back pain
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
18.8%
3/16 • Number of events 4 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
General disorders
Pain in the middle of Chest brought on by physical activity
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
General disorders
Retrosternal Chest Pain
|
56.2%
9/16 • Number of events 9 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath brough on by physical activity
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Infections and infestations
Diverticulitis
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Hiatal Hernia
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Schatzski's Ring
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Diverticulosis of Sigmoid Colon
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Excessive Gas
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
General disorders
Patient with complaint of left lateral wall discomfort in left axilla. Occasional/short lasting
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Infections and infestations
Upper Respiratory Infection
|
6.2%
1/16 • Number of events 2 • 3 years
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
General disorders
Low grade fever
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Infections and infestations
Minor Cold
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
More servere hearburn than Baseline
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Burping
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis with asthma exacerbation
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Worsening of asthma
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Asthma Attack
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Bleeding gastric ulcer
|
6.2%
1/16 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
Exacerbation of reflux due to medication taken for pneumonia
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Gastric fistula
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Vascular disorders
High Blood Pressure
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Infections and infestations
Pneumonia
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Infections and infestations
Viral illness accompanied by headache, nauseau, and vomiting
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Torn ligmament in left shoulder
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
General disorders
Weakness
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Infections and infestations
Cold like symtoms
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Exacerbated GERD symptoms - gagging, coughing, mucus due to stress when patient's mother was ill.
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Infections and infestations
Tooth abscess
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Worsening of GERD Symptoms
|
12.5%
2/16 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
More severe heartburn than baseline
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Exacerbation of GERD symptoms similar to baseline
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Increase in severity of nausea
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Asthma Exacerbation
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Increased Burping
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
General disorders
Mild Retrosternal Chest Pain
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Difficulty Swallowing
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
General disorders
Chest Pain
|
12.5%
2/16 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
Trouble Swallowing
|
6.2%
1/16 • Number of events 1 • 3 years
|
Additional Information
Director, Endoscopy Clinical Affairs
Boston Scientific
Phone: 1-508-333-1015
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place