GastroparesisNCT06661668
Laparoscopic Implantation of a Gastric Pacemaker in the Treatment of Gastroparesis
An observational study of Gastroparesis and Gastroparesis Postoperative, run by Evangelic Hospital Kalk Cologne at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroparesis, Gastroparesis Postoperative, Gastroparesis Nondiabetic
- What is being tested?
- Gastric pacemaker (Enterra system) implantation
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2023to 31 Dec 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The study includes patients with (1) scintigraphically proven gastroparesis, (2) failed conservative therapy, (3) who undergo laparoscopic gastric pacemaker implantation.
Who may be able to join
- Scintigraphically proven gastroparesis
- Failed conservative therapy
- Severe impairment of quality of life
- Written informed consent
- German language
Who cannot join
- Age < 18 years
- Prior gastric resection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Functional Upper GI Surgery
Cologne, North Rhine-Westphalia, 51103
Jessica M Leers, Prof., 0221-82892800, jessica.leers@uk-koeln.de
About this study
Official title: Laparoscopic Implantation of a Gastric Pacemaker is a Low-complication Alternative for Gastroparesis
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.
Read the 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.
- Conditions
- Gastroparesis, Gastroparesis Postoperative, Gastroparesis Nondiabetic, Gastroparesis With Diabetes Mellitus
- Being tested
- Gastric pacemaker (Enterra system) implantation
- Keywords
- Gastroparesis, Gastric pacemaker
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric pacemaker (Enterra system) implantationDevice
Laparascopic implantation of a gastric pacemaker (Enterra system) for patients with therapy refractive gastroparesis
| Study group | Role | What they receive |
|---|---|---|
| Gastroparesis group | Patients scintigraphically proven gastroparesis and failed conservative therapy who undergo laparoscopic gastric pacemaker implantation Receives: Device: Gastric pacemaker (Enterra system) implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms
Symptom severity/Improvement of symptoms pre-/post gastric pacemaker implantation using the standardized Gastroparesis Cardinal Symptom Index (GCSI). The GCSI is based on three subscales: post-prandial fullness/early satiety (4 items); nausea/vomiting (3 items), and bloating (2 items). A total score of 45 can be achieved. A high score indicates more severe symptoms.
Measured: 5 years
Health-related quality of life
Health-related quality of life pre-/post gastric pacemaker implantation using the GIQLI questionnaire (Gastrointestinal Quality of Life Index). GIQLI is a validated instrument to assess HRQoL among patients with gastrointestinal disorders. The questionnaire consists of 36 questions and is subdivided into five subcategories (symptoms, emotion, physical function, social function, and medical treatment). Total scores between 0 and 144 can be achieved. Respective total scores for the specific subcategories are symptoms=76, emotions=20, physical=28, and social=20. Higher scores represent a higher HRQoL.17
Measured: 5 years
Secondary outcomes (2)
Hospital admission
Frequency of hospital admission for further treatment pre/post gastric pacemaker implantation
Measured: 5 years
Perioperative complication rate
Perioperative complications such as wound infection, pain, dysfunctional device
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start1 Jan 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Evangelic Hospital Kalk Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- Enterra Medical, Inc.
- Responsible party
- Principal investigator, Jessica Leers, University of Cologne
- Investigators
- Jessica M Leers, Prof., Principal investigator, Department of Functional Upper GI Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661668
- Sponsor's protocol ID
- Gastroparesis_Enterra
- Status last verified
- Oct 2024
- First submitted
- 29 Jan 2024
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Implantation of a Gastric Pacemaker is a Low-complication Alternative for Gastroparesis
- ClinicalTrials.gov ID
- NCT06661668
- Acronym / sponsor ID
- Gastroparesis_Enterra
- Conditions
- Gastroparesis, Gastroparesis Postoperative, Gastroparesis Nondiabetic, Gastroparesis With Diabetes Mellitus
- Keywords
- Gastroparesis, Gastric pacemaker
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Evangelic Hospital Kalk CologneUniversity, hospital or other
- Collaborators
- Enterra Medical, Inc.
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastroparesis group | – | Device: Gastric pacemaker (Enterra system) implantationPatients scintigraphically proven gastroparesis and failed conservative therapy who undergo laparoscopic gastric pacemaker implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study includes patients with (1) scintigraphically proven gastroparesis, (2) failed conservative therapy, (3) who undergo laparoscopic gastric pacemaker implantation.
Key inclusion criteria (5 listed)
- Scintigraphically proven gastroparesis
- Failed conservative therapy
- Severe impairment of quality of life
- Written informed consent
- German language
Key exclusion criteria (2 listed)
- Age < 18 years
- Prior gastric resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric pacemaker (Enterra system) implantationLaparascopic implantation of a gastric pacemaker (Enterra system) for patients with therapy refractive gastroparesis | Device | Gastroparesis group |
Primary outcome
Symptoms
Time frame: 5 years
Symptom severity/Improvement of symptoms pre-/post gastric pacemaker implantation using the standardized Gastroparesis Cardinal Symptom Index (GCSI). The GCSI is based on three subscales: post-prandial fullness/early satiety (4 items); nausea/vomiting (3 items), and bloating (2 items). A total score of 45 can be achieved. A high score indicates more severe symptoms.
Health-related quality of life
Time frame: 5 years
Health-related quality of life pre-/post gastric pacemaker implantation using the GIQLI questionnaire (Gastrointestinal Quality of Life Index). GIQLI is a validated instrument to assess HRQoL among patients with gastrointestinal disorders. The questionnaire consists of 36 questions and is subdivided into five subcategories (symptoms, emotion, physical function, social function, and medical treatment). Total scores between 0 and 144 can be achieved. Respective total scores for the specific subcategories are symptoms=76, emotions=20, physical=28, and social=20. Higher scores represent a higher HRQoL.17
2 secondary outcomes
Hospital admission
Time frame: 5 years
Perioperative complication rate
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica M Leers, Prof. principal investigator
Department of Functional Upper GI Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroparesis and Gastroparesis Postoperative, run by Evangelic Hospital Kalk Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica M Leers, Prof. (+49 221 ext. 82892800, jessica.leers@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.