Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2026-01-02 @ 1:21 AM
Study NCT ID:
NCT06661668
Status:
RECRUITING
Last Update Posted:
2025-08-12
First Post:
2024-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Implantation of a Gastric Pacemaker in the Treatment of Gastroparesis
Sponsor:
Evangelic Hospital Kalk Cologne
Organization:
Study Overview
Official Title:
Laparoscopic Implantation of a Gastric Pacemaker is a Low-complication Alternative for Gastroparesis
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Gastroparesis is a burdensome condition that is caused by abnormal motor function of the stomach that results in delayed gastric emptying. It typically manifests with bloating, nausea, vomiting, abdominal pain, and even excessive weight loss and dehydration. The most common causes of gastroparesis are idiopathic, diabetic, medication-induced or iatrogenic (postsurgical) gastroparesis.
Implantation of a gastric neurostimulation device is a surgical option to improve gastric emptying in patients with medication-refractory gastroparesis. Enterra® system is a gastric electrical stimulation that sends mild pulses through leads implanted in the stomach wall that stimulate gastric smooth muscles and nerves in order to improve symptoms and quality of life.
Aim of the investogators' registry trial is to evaluate the feasibility and efficacy of laparoscopic gastric pacemaker implantation for electrical stimulation (Enterra® system). Primary endpoints of the study are symptom severity, health-related quality of life, and frequency of hospitalization before and after pacemaker implantation, perioperative complication rate, and cost effectiveness.
Implantation of a gastric neurostimulation device is a surgical option to improve gastric emptying in patients with medication-refractory gastroparesis. Enterra® system is a gastric electrical stimulation that sends mild pulses through leads implanted in the stomach wall that stimulate gastric smooth muscles and nerves in order to improve symptoms and quality of life.
Aim of the investogators' registry trial is to evaluate the feasibility and efficacy of laparoscopic gastric pacemaker implantation for electrical stimulation (Enterra® system). Primary endpoints of the study are symptom severity, health-related quality of life, and frequency of hospitalization before and after pacemaker implantation, perioperative complication rate, and cost effectiveness.
Detailed Description:
Gastroparesis is a burdensome condition that is caused by abnormal motor function of the stomach that results in delayed gastric emptying. It typically manifests with bloating, nausea, vomiting, abdominal pain, and even excessive weight loss and dehydration. The most common causes of gastroparesis are idiopathic, diabetic, medication-induced or iatrogenic (postsurgical) gastroparesis.
After ruling out mechanical obstruction as an underlying cause of gastroparesis using endoscopy or computed tomography, further assessment includes gastric emptying studies by scintigraphy to confirm the presence of delayed gastric emptying. Severity of symptoms and impact on health-related quality of life can be assessed using the Gastroparesis Cardinal Symptom Index (GCSI) and Gastrointestinal Quality of Life Index (GIQLI).
Management of gastroparesis includes assessment of nutritional status, correction of fluid, electrolytes and nutritional deficiencies, symptomatic therapy, management of the underlying cause of gastroparesis, and improvement of gastric emptying. Implantation of a gastric neurostimulation device is a surgical option to improve gastric emptying in patients with medication-refractory gastroparesis. Enterra® system is a gastric electrical stimulation that sends mild pulses through leads implanted in the stomach wall that stimulate gastric smooth muscles and nerves in order to improve symptoms and quality of life.
Aim of this registry trial is to evaluate the feasibility and efficacy of laparoscopic gastric pacemaker implantation for electrical stimulation (Enterra® system). Primary endpoints of the study are symptom severity, health-related quality of life, and frequency of hospitalization before and after pacemaker implantation, perioperative complication rate, and cost effectiveness.
It is hypothesized that implantation of the Enterra systems leads to a significant improvement of symptoms as well as an increase in health-related quality of life in patients with gastroparesis.
After ruling out mechanical obstruction as an underlying cause of gastroparesis using endoscopy or computed tomography, further assessment includes gastric emptying studies by scintigraphy to confirm the presence of delayed gastric emptying. Severity of symptoms and impact on health-related quality of life can be assessed using the Gastroparesis Cardinal Symptom Index (GCSI) and Gastrointestinal Quality of Life Index (GIQLI).
Management of gastroparesis includes assessment of nutritional status, correction of fluid, electrolytes and nutritional deficiencies, symptomatic therapy, management of the underlying cause of gastroparesis, and improvement of gastric emptying. Implantation of a gastric neurostimulation device is a surgical option to improve gastric emptying in patients with medication-refractory gastroparesis. Enterra® system is a gastric electrical stimulation that sends mild pulses through leads implanted in the stomach wall that stimulate gastric smooth muscles and nerves in order to improve symptoms and quality of life.
Aim of this registry trial is to evaluate the feasibility and efficacy of laparoscopic gastric pacemaker implantation for electrical stimulation (Enterra® system). Primary endpoints of the study are symptom severity, health-related quality of life, and frequency of hospitalization before and after pacemaker implantation, perioperative complication rate, and cost effectiveness.
It is hypothesized that implantation of the Enterra systems leads to a significant improvement of symptoms as well as an increase in health-related quality of life in patients with gastroparesis.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: