Trial Outcomes & Findings for Enterra Therapy Clinical Study (Gastric Stimulation for Gastroparesis) (NCT NCT00157755)

NCT ID: NCT00157755

Last Updated: 2010-03-10

Results Overview

Diaries were used to record daily vomiting episodes for 28 days prior to each office follow-up visit. The weekly vomiting frequency (WVF) was based on the average number of weekly vomiting episodes recorded in the patient diary. The percent reduction is calculated as ((WVF during OFF - WVF during ON)/ (WVF during OFF))\*100%. A positive reduction represents an improvement in WVF when the device was ON.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 87 participants
• Primary outcome timeframe: 4.5 months and 7.5 months
• Results posted on: 2010-03-10

Participant Flow

Participant milestones

Measure	Diabetic: Not Randomized This group contains subjects that were enrolled and analyzed as part of the diabetic cohort. These subjects exited the study prior to randomization at 1.5 months.	Idiopathic: ON First, Then OFF This group contains subjects that were enrolled and analyzed as part of the idiopathic cohort. During the crossover phase of the study, this subject had the device ON for three months, followed by device OFF for three months.	Idiopathic: OFF First, Then ON This group contains subjects that were enrolled and analyzed as part of the idiopathic cohort. During the crossover phase of the study, this subject had the device OFF for three months, followed by device ON for three months.	Idiopathic: Not Randomized This group contains subjects that were enrolled and analyzed as part of the idiopathic cohort. These subjects exited the study prior to randomization at 1.5 months.	Diabetic: ON First, Then OFF This group contains subjects that were enrolled and analyzed as part of the diabetic cohort. During the crossover phase of the study, this subject had the device ON for three months, followed by device OFF for three months.	Diabetic: OFF First, Then ON This group contains subjects that were enrolled and analyzed as part of the diabetic cohort. During the crossover phase of the study, this subject had the device OFF for three months, followed by device ON for three months.
Overall Study STARTED	10	15	12	5	26	19
Overall Study COMPLETED	3	11	10	0	24	15
Overall Study NOT COMPLETED	7	4	2	5	2	4

Reasons for withdrawal

Measure	Diabetic: Not Randomized This group contains subjects that were enrolled and analyzed as part of the diabetic cohort. These subjects exited the study prior to randomization at 1.5 months.	Idiopathic: ON First, Then OFF This group contains subjects that were enrolled and analyzed as part of the idiopathic cohort. During the crossover phase of the study, this subject had the device ON for three months, followed by device OFF for three months.	Idiopathic: OFF First, Then ON This group contains subjects that were enrolled and analyzed as part of the idiopathic cohort. During the crossover phase of the study, this subject had the device OFF for three months, followed by device ON for three months.	Idiopathic: Not Randomized This group contains subjects that were enrolled and analyzed as part of the idiopathic cohort. These subjects exited the study prior to randomization at 1.5 months.	Diabetic: ON First, Then OFF This group contains subjects that were enrolled and analyzed as part of the diabetic cohort. During the crossover phase of the study, this subject had the device ON for three months, followed by device OFF for three months.	Diabetic: OFF First, Then ON This group contains subjects that were enrolled and analyzed as part of the diabetic cohort. During the crossover phase of the study, this subject had the device OFF for three months, followed by device ON for three months.
Overall Study Death	3	2	0	0	2	3
Overall Study Lost to Follow-up	1	0	0	0	0	0
Overall Study Withdrawal by Subject	1	1	1	2	0	0
Overall Study Explant due to infection	1	0	0	0	0	0
Overall Study Medical reason	1	1	0	0	0	0
Overall Study Study site closure	0	0	0	0	0	1
Overall Study Subject non-compliance	0	0	0	1	0	0
Overall Study Study completion	0	0	1	2	0	0

Baseline Characteristics

Enterra Therapy Clinical Study (Gastric Stimulation for Gastroparesis)

Baseline characteristics by cohort

Measure	Diabetic n=55 Participants This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.	Idiopathic n=32 Participants This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.	Total n=87 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	55 Participants n=5 Participants	32 Participants n=7 Participants	87 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	38.3 years STANDARD_DEVIATION 9.8 • n=5 Participants	39.4 years STANDARD_DEVIATION 10.4 • n=7 Participants	38.7 years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	26 Participants n=7 Participants	62 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	6 Participants n=7 Participants	25 Participants n=5 Participants
Region of Enrollment United States	55 participants n=5 Participants	32 participants n=7 Participants	87 participants n=5 Participants

PRIMARY outcome

Timeframe: 4.5 months and 7.5 months

Population: The analysis population included subjects who were randomized, completed the study through the end of the blinded crossover period and provided evaluable measurements.

Diaries were used to record daily vomiting episodes for 28 days prior to each office follow-up visit. The weekly vomiting frequency (WVF) was based on the average number of weekly vomiting episodes recorded in the patient diary. The percent reduction is calculated as ((WVF during OFF - WVF during ON)/ (WVF during OFF))*100%. A positive reduction represents an improvement in WVF when the device was ON.

Outcome measures

Measure	Diabetic n=32 Participants This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.	Idiopathic n=20 Participants This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
Percent Reduction in Frequency of Weekly Vomiting Episodes When the Device is Turned ON, Relative to When the Device is Turned OFF	0 percent reduction in WVF Interval -300.0 to 100.0	17.3 percent reduction in WVF Interval -450.0 to 100.0

SECONDARY outcome

Timeframe: 4.5 months and 7.5 months

Population: The analysis population included subjects who were randomized, completed the study through the end of the blinded crossover period and provided evaluable measurements.

A symptom interview was conducted at each visit to assess vomiting, nausea, early satiety, bloating, postprandial fullness, epigastric pain and epigastric burning. The scale for each symptom ranges from 0 to 4, with 0 being absence of symptoms and 4 being extremely frequent (≥ 7 episodes per week). Total symptom score (TSS) is the sum of the individual frequency symptom scores. The percent reduction is calculated as ((TSS during OFF - TSS during ON)/ (TSS during OFF))*100%. A positive reduction represents an improvement in TSS when the device was ON.

Outcome measures

Measure	Diabetic n=36 Participants This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.	Idiopathic n=21 Participants This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
Percent Reduction in Symptom Score When the Device is Turned ON, Relative to When the Device is Turned OFF	0 Percent reduction in symptom score Interval -250.0 to 100.0	0 Percent reduction in symptom score Interval -87.5 to 100.0

SECONDARY outcome

Timeframe: baseline and 12 months

Population: The analysis population included subjects who were randomized, completed the study at 12 months and provided evaluable measurements.

Diaries were used to record daily vomiting episodes for 28 days prior to each office follow-up visit. The weekly vomiting frequency (WVF) was based on the average number of weekly vomiting episodes recorded in the patient diary. The percent reduction is calculated as ((WVF at baseline - WVF at 12 months)/ (WVF at baseline))*100%. A positive reduction represents an improvement in WVF at 12 months.

Outcome measures

Measure	Diabetic n=36 Participants This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.	Idiopathic n=18 Participants This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
Percent Reduction in the Frequency of Weekly Vomiting Episodes at 12 Months Compared to Baseline	67.8 Percent reduction in WVF Interval -114.9 to 100.0	87.1 Percent reduction in WVF Interval -80.4 to 100.0

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 12 months

Population: The analysis population included subjects who were randomized, completed the study at 12 months and provided evaluable measurements.

Responders were defined as having a 50% or greater reduction of WVF from baseline to 12 months. The percentage of responders was estimated as the proportion of the responders among all subjects who finished the 12-month visit. The percentage of responders was tested to determine if it was statistically greater than 50%.

Outcome measures

Measure	Diabetic n=36 Participants This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.	Idiopathic n=18 Participants This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
Percentage of Responders at 12 Months	69 Percentage of responders	94 Percentage of responders

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 12 months

Population: The analysis population included subjects who were randomized and completed the study at 12 months.

A symptom interview was conducted at each visit to assess vomiting, nausea, early satiety, bloating, postprandial fullness, epigastric pain and epigastric burning. The scale for each symptom ranges from 0 to 4, with 0 being absence of symptoms and 4 being extremely frequent (≥ 7 episodes per week). Total symptom score (TSS) is the sum of the individual frequency symptom scores. The change is calculated as TSS at baseline - TSS at 12 months. A positive change represents an improvement in TSS at 12 months.

Outcome measures

Measure	Diabetic n=39 Participants This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.	Idiopathic n=19 Participants This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
Change in Symptom Score at 12 Months Compared to Baseline.	6.79 Scores on a scale Standard Deviation 8.05	8.74 Scores on a scale Standard Deviation 7.46

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 12 months

Population: The analysis population included subjects who were randomized and completed the study at 12 months.

The QOL scores were collected using the SF-36 questionnaire, which included the scores in the following domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health. The raw score of 0 represents poor health and 100 represents best health. The physical component summary (PCS) score is a norm based score calculated from the raw scores of these 8 domains with a focus on physical health. The change in PCS is calculated as PCS at baseline - PCS at 12 months. A negative change in PCS represents an improvement in QOL.

Outcome measures

Measure	Diabetic n=32 Participants This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.	Idiopathic n=20 Participants This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
Change in Quality of Life (QOL) at 12 Months Compared to Baseline (Physical Component Summary)	-6.9 Scores on a scale Standard Deviation 8.97	-5.2 Scores on a scale Standard Deviation 10.43

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 12 months

Population: The analysis population included subjects who were randomized and completed the study at 12 months.

The QOL scores were collected using the SF-36 questionnaire, which included the scores in the following domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health. The raw score of 0 represents poor health and 100 represents best health. The mental component summary (MCS) score is a norm based score calculated from the raw scores of these 8 domains with a focus on mental health. The change in MCS is calculated as MCS at baseline - MCS at 12 months. A negative change in MCS represents an improvement in QOL.

Outcome measures

Measure	Diabetic n=39 Participants This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.	Idiopathic n=19 Participants This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
Change in Quality of Life at 12 Months Compared to Baseline (Mental Component Summary)	-6.81 Scores on a scale Standard Deviation 15.15	-7.15 Scores on a scale Standard Deviation 7.75

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 12 months

Population: The analysis population included subjects who were randomized, completed the study at 12 months and provided evaluable measurements.

Gastric emptying was evaluated using a standardized scintigraphy method and a low fat egg substitute test meal. After standard meal and marker preparation, the subsequent images were taken at 2 hours and 4 hours and percentage of gastric retention was evaluated. Change in 2-hour GET is calculated as % of gastric retention at 2 hours at baseline - % of gastric retention at 2 hours at 12 months. A positive change represents an improvement in gastric emptying at 12 months.

Outcome measures

Measure	Diabetic n=28 Participants This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.	Idiopathic n=16 Participants This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
Change in Gastric Emptying Results at 12 Months Compared to Baseline (2 Hours)	18 Percent retention Interval 11.0 to 37.5	17.5 Percent retention Interval -0.5 to 31.0

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 12 months

Population: The analysis population included subjects who were randomized, completed the study at 12 months and provided evaluable measurements.

Gastric emptying was evaluated using a standardized scintigraphy method and a low fat egg substitute test meal. After standard meal and marker preparation, the subsequent images were taken at 2 hours and 4 hours and percentage of gastric retention was evaluated. Change in 4-hour GET is calculated as % of gastric retention at 4 hours at baseline - % of gastric retention at 4 hours at 12 months. A positive change represents an improvement in gastric emptying at 12 months.

Outcome measures

Measure	Diabetic n=28 Participants This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.	Idiopathic n=16 Participants This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
Change in Gastric Emptying Results at 12 Months Compared to Baseline (4 Hours)	22 Percent retention Interval 7.5 to 39.5	13.5 Percent retention Interval -11.0 to 17.0

Adverse Events

Diabetic

Serious events: 8 serious events

Other events: 13 other events

Deaths: 0 deaths

Idiopathic

Serious events: 4 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Diabetic n=55 participants at risk This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.	Idiopathic n=32 participants at risk This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
Respiratory, thoracic and mediastinal disorders Apnoeic attack	1.8% 1/55 • Number of events 1 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.	0.00% 0/32 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.
Surgical and medical procedures Central venous catheterisation	1.8% 1/55 • Number of events 1 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.	0.00% 0/32 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.
General disorders Chest pain	1.8% 1/55 • Number of events 1 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.	0.00% 0/32 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.
General disorders Death	0.00% 0/55 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.	3.1% 1/32 • Number of events 1 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.
Metabolism and nutrition disorders Diabetic ketoacidosis	1.8% 1/55 • Number of events 1 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.	0.00% 0/32 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.8% 1/55 • Number of events 1 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.	0.00% 0/32 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.
General disorders High lead impedance	1.8% 1/55 • Number of events 1 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.	0.00% 0/32 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.
Gastrointestinal disorders Impaired gastric emptying	1.8% 1/55 • Number of events 1 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.	0.00% 0/32 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.
General disorders Implant site haematoma	1.8% 1/55 • Number of events 1 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.	0.00% 0/32 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.
Infections and infestations Implant site infection	1.8% 1/55 • Number of events 1 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.	0.00% 0/32 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.
General disorders Lead migration/dislodgment	1.8% 1/55 • Number of events 2 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.	3.1% 1/32 • Number of events 1 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.
General disorders Migration of implant	1.8% 1/55 • Number of events 2 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.	0.00% 0/32 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.
General disorders Neurostimulator migration	0.00% 0/55 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.	3.1% 1/32 • Number of events 1 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.
Nervous system disorders Paraesthesia	0.00% 0/55 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.	3.1% 1/32 • Number of events 1 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.
Infections and infestations Pneumonia	1.8% 1/55 • Number of events 1 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.	0.00% 0/32 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.
Cardiac disorders Sinus tachycardia	1.8% 1/55 • Number of events 1 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.	0.00% 0/32 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.
Infections and infestations Staphylococcal bacteraemia	1.8% 1/55 • Number of events 1 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.	0.00% 0/32 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.

Other adverse events

Measure	Diabetic n=55 participants at risk This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.	Idiopathic n=32 participants at risk This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
Gastrointestinal disorders Abdominal pain	7.3% 4/55 • Number of events 4 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.	0.00% 0/32 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.
General disorders Lead impedance NOS or high lead impedance	20.0% 11/55 • Number of events 11 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.	18.8% 6/32 • Number of events 7 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.
Nervous system disorders Paraesthesia	0.00% 0/55 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.	9.4% 3/32 • Number of events 3 • Adverse events were collected throughout the duration of the study beginning at the time of patient enrollment until discontinuation from the study. All adverse events collected in the study were categorized by the investigator and reviewed by an adverse events commitee for causality. Tables below include all events that were classified as device-related, therapy-related, or undetermined. Events determined to be related to the patient's underlying condition (patient-related) are not included.

Additional Information

Clinical Program Manager

Medtronic Neuromodulation

Phone: 763-526-8172

Email: medtronicneurotrials@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60