Assessing a new technique for placing gastrostomy tubes in children
Safety and Efficacy of Endoscopic Assisted Push Gastrostomy Using Gastropexy Technique
CHRISTUS Health · NCT04096456
This study is testing a new way to place feeding tubes in children to see if it is safer and has fewer complications than the traditional method.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | N/A to 17 Years |
| Sex | All |
| Sponsor | CHRISTUS Health (other) |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT04096456 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the safety and efficacy of an endoscopic gastropexy technique for placing gastrostomy tubes in pediatric patients. The approach involves securing the stomach to the abdominal wall using T-fasteners, allowing for immediate placement of a low profile gastrostomy tube. The study compares outcomes, including immediate and long-term complications, between this technique and the traditional endoscopic pull method. Data will be collected from patient charts spanning from 2005 to 2015 to assess complications such as pain, bleeding, and infection.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 0-17 years requiring an alternate means of nutrition through gastrostomy placement.
Not a fit: Patients who do not require gastrostomy placement or are outside the age range of 0-17 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could reduce complications associated with gastrostomy tube placement in children.
How similar studies have performed: While traditional methods have been widely studied, this specific gastropexy technique is relatively novel and has not been extensively tested in pediatric populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Inclusion criteria is pediatric patients requiring an alternate means of nutrition with gastrostomy placement. Subjects ages 0-17 years of age. Data created starting 01/01/2005 to 07/31/2015. Exclusion Criteria: * Patients that do not meet inclusion criteria.
Where this trial is running
San Antonio, Texas
- The Children's Hospital of San Antonio — San Antonio, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Javier Monagas, MD — The Children's Hospital of San Antonio
- Study coordinator: Javier Monagas, MD
- Email: monagas@bcm.tmc.edu
- Phone: 210-704-4849
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gastrostomy, Gastrostomy Complications, Gastrostomy Tube Site Complication, Pain, Postoperative, Gastropexy, Endoscopic Gastropexy, Gastrostomy Tube