NCT06372132

Brief Summary

Study design: A randomized non-blinded controlled clinical trial with two study arms (G-POEM and PEG-J). Treatment success is measured using the GCSI at baseline before intervention and six months after intervention with a possible cross-over after six months of follow-up. Study population: 50 patients with therapy refractory GP on dietary advices, prokinetics and possibly tube feeding (gastric rest) who have already been referred for additional treatment options in the form of PEG-J/ G-POEM. Intervention: Group 1 will receive G-POEM treatment and group 2 will receive PEG-J treatment. Main study parameters/endpoints: A clinically meaningful treatment success six months after G-POEM treatment, measured using the GCSI-score defined as a decrease of 1 or more point.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Mar 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Mar 2024Jan 2028

First Submitted

Initial submission to the registry

February 29, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

March 14, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

2.8 years

First QC Date

February 29, 2024

Last Update Submit

April 16, 2024

Conditions

Gastroparesis

Outcome Measures

Primary Outcomes (1)

  • Number of patients with treatment success using the GCSI-score in patients with refractory GP undergoing G-POEM compared to patients receiving a PEG-J at t = 6 months.

    A treatment success will be defined as a decrease of at least one point on the GCSI (range 0-5), representing a clinically relevant difference, six months after intervention in comparison with baseline before intervention.

    6 months

Secondary Outcomes (5)

  • Number of patients with treatment success using the GCSI-score in patients with refractory GP undergoing G-POEM compared to patients receiving a PEG-J at t = 12 months.

    12 months

  • Degree of quality of life using the PAGI-QOL in the G-POEM group in comparison with the PEG-J intervention six months after intervention.

    6 months

  • Number and severity of (s)AEs in the treatment groups.

    12 months

  • Predictive value of the etiology of gastroparesis on treatment outcomes following G-POEM by measuring the rate of treatment success quantified by improvements in the GCSI-score.

    6-12 months

  • Predictive value of the etiology of gastroparesis on treatment outcomes following PEG-J by measuring the rate of treatment success quantified by improvements in the GCSI-score.

    6-12 months

Study Arms (2)

G-POEM

OTHER
Procedure: G-POEM

PEG-J

ACTIVE COMPARATOR
Procedure: G-POEM

Interventions

G-POEMPROCEDURE

Gastric Per-Oral Endoscopic Pyloromyotomy

Also known as: PEG J
G-POEMPEG-J

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with GP
  • C octanoic acid test or gastric scintigraphy (minimal 4-hour measurement) within the past twelve months
  • years old

You may not qualify if:

  • \< 18 years old
  • Medical history of stomach surgery in which resection of antrum and/ or pylorus took place
  • Medical history of surgical or laparoscopic pyloromyotomy
  • Gastric bypass
  • Current opioid use
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Zuid-Limburg, 6229 HX, Netherlands

RECRUITING

MeSH Terms

Conditions

Gastroparesis

Interventions

Pyloromyotomy

Condition Hierarchy (Ancestors)

Stomach DiseasesGastrointestinal DiseasesDigestive System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDigestive System Surgical ProceduresSurgical Procedures, OperativeGastrectomyMyotomy

Central Study Contacts

Kim Sweerts

CONTACT

+31 88 388 7298kim.sweerts@maastrichtuniversity.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2024

First Posted

April 17, 2024

Study Start

March 14, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

April 17, 2024

Record last verified: 2024-04

Locations

NL(1)