Long Term Enteral Tube FeedingNCT04030871
A Randomized, Pilot Study Comparing Cost Effectiveness on Two Commercially Available Gastric Feeding Tubes
A study testing Capsule Dome G-Tube and Balloon Bolus feeding tube in people with Long Term Enteral Tube Feeding, run by Ohio State University at 1 site in United States.
Trial summary
This document is a protocol for a human research study. This study is to be conducted according to US and international standards of Good Clinical Practice (International Conference on Harmonization ICHE6, R2), the Code of Federal Regulations Title 21 parts 803 and 812, and other applicable government regulations and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Long Term Enteral Tube Feeding
- What is being tested?
- Capsule Dome G-Tube and Balloon Bolus feeding tube
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2019to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed an IRB-approved informed consent form for the study.
- Adults (18-75 years of age)
- Requirement of long term enteral tube feeding (> to 12 months) and are due for a change of their initial or prior replacement bolus Percutaneous Endoscopic Gastrostomy (PEG) tube.
- Ability to consent for the procedure and study.
- Subjects must be able to communicate in english via telephone and understand the assessment checklists.
- Expected to survive 12 months. Exclusion Criteria
Show all 13Show fewer
- The following subjects will not be eligible for inclusion in the study:
- Enteral feeding is not necessary for at least 12 months,
- A medical condition that makes it impossible for them to communicate via telephone
- Subjects requiring feeding into the jejunum via a combined gastroenterostomy-jejunostomy tube
- Subjects who require endoscopic replacement of their current gastrostomy tube.
- Impaired cognition, inability to provide assessment feedback by telephone.
- Subjects not expected to survive > 12 months
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Investigator-Initiated, Randomized, Pilot Study Comparing Cost Effectiveness Two Commercially Available Gastric Feeding Tubes (Capsule Dome G-Tube Versus Balloon Bolus Feeding Tube).
This document is a protocol for a human research study. This study is to be conducted according to US and international standards of Good Clinical Practice (International Conference on Harmonization ICHE6, R2), the Code of Federal Regulations Title 21 parts 803 and 812, and other applicable government regulations and Institutional research policies and procedures. The purpose of the study is to compare the cost effectiveness and tolerability of standard of care gastrostomy tubes to newer capsule dome gastrostomy tubes. The newer tubes are significantly more expensive, therefore the aims of this study will be to determine economic feasibility of going to the new model. Data are lacking on the newer g-tubes in terms of longevity and cost-effectiveness
Read the detailed description
Gastrostomy tubes are enteral feeding devices that are designed to provide delivery of nutrients, fluids, medications directly into the stomach, bypassing the mouth and esophagus. These devices are also known as gastrostomy tubes (G-tubes) or percutaneous endoscopic gastrostomy tube (PEG tube). These are used when patients have conditions that make them unable to swallow. While parenteral (Intravenous) nutrition and nasogastric tubes are also nutritional-support methods. A variety of g-tube designs have been used in pediatric to adult populations. The insertion of a g-tube is one of the most common endoscopic procedures and is relatively safe. The OSU endoscopy lab placed 381 g-tubes in 2018.
The most common G-tube used by the OSU Endoscopy Lab is the Balloon Bolus feeding tube. In 2017 the Capsule Dome G-Tube became commercially available. The cost of the Capsule dome g-tube is twice as expensive as the standard balloon g-tube. The insertion costs would be comparable.
The need to perform a pilot comparative study of the two g-tubes is necessary to improve our physicians understanding of the potential cost-effectiveness that longer patency we could gather from the alternative device.
- Conditions
- Long Term Enteral Tube Feeding
- Being tested
- Capsule Dome G-Tube, Balloon Bolus feeding tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsule Dome G-TubeDevice
Feeding replacement tubes with two different FDA approved devices in forty subjects
Balloon Bolus feeding tubeDevice
Feeding replacement tubes with two different FDA approved devices in forty subjects
| Study group | Role | What they receive |
|---|---|---|
| Capsule Dome G-Tube | Active comparator | Capsule Dome G-Tube Receives: Device: Capsule Dome G-Tube |
| Balloon Bolus feeding tube | Active comparator | Balloon Bolus feeding tube Receives: Device: Balloon Bolus feeding tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of PEG tube device longevity
Time (metric is looking at Q3 month follow-up for one year)
Measured: Up to twelve months
Secondary outcomes (1)
Measure the cost difference of two PEG tube devices
Metrics evaluated using a cost-effectiveness analysis
Measured: Up to twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start25 Oct 2019
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Why it stopped: Inability to recruit study participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long Term Enteral Tube FeedingStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Single-Center, Investigator-Initiated, Randomized, Pilot Study
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Papachristou, Ohio State University
- Investigators
- Jeffery R Groce, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030871
- Sponsor's protocol ID
- New-41476
- Status last verified
- Feb 2026
- First submitted
- 29 May 2019
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Investigator-Initiated, Randomized, Pilot Study Comparing Cost Effectiveness Two Commercially Available Gastric Feeding Tubes (Capsule Dome G-Tube Versus Balloon Bolus Feeding Tube).
- ClinicalTrials.gov ID
- NCT04030871
- Acronym / sponsor ID
- New-41476
- Conditions
- Long Term Enteral Tube Feeding
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to recruit study participants
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 24 Jul 2019 (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.
This document is a protocol for a human research study. This study is to be conducted according to US and international standards of Good Clinical Practice (International Conference on Harmonization ICHE6, R2), the Code of Federal Regulations Title 21 parts 803 and 812, and other applicable government regulations and Institutional research policies and procedures. The purpose of the study is to compare the cost effectiveness and tolerability of standard of care gastrostomy tubes to newer capsule dome gastrostomy tubes. The newer tubes are significantly more expensive, therefore the aims of this study will be to determine economic feasibility of going to the new model. Data are lacking on the newer g-tubes in terms of longevity and cost-effectiveness
Detailed description
Gastrostomy tubes are enteral feeding devices that are designed to provide delivery of nutrients, fluids, medications directly into the stomach, bypassing the mouth and esophagus. These devices are also known as gastrostomy tubes (G-tubes) or percutaneous endoscopic gastrostomy tube (PEG tube). These are used when patients have conditions that make them unable to swallow. While parenteral (Intravenous) nutrition and nasogastric tubes are also nutritional-support methods. A variety of g-tube designs have been used in pediatric to adult populations. The insertion of a g-tube is one of the most common endoscopic procedures and is relatively safe. The OSU endoscopy lab placed 381 g-tubes in 2018.
The most common G-tube used by the OSU Endoscopy Lab is the Balloon Bolus feeding tube. In 2017 the Capsule Dome G-Tube became commercially available. The cost of the Capsule dome g-tube is twice as expensive as the standard balloon g-tube. The insertion costs would be comparable.
The need to perform a pilot comparative study of the two g-tubes is necessary to improve our physicians understanding of the potential cost-effectiveness that longer patency we could gather from the alternative device.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Single-Center, Investigator-Initiated, Randomized, Pilot Study
| Arm | Type | Receives |
|---|---|---|
| Capsule Dome G-Tube | Active comparator | Device: Capsule Dome G-TubeCapsule Dome G-Tube |
| Balloon Bolus feeding tube | Active comparator | Device: Balloon Bolus feeding tubeBalloon Bolus feeding tube |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed an IRB-approved informed consent form for the study.
- Adults (18-75 years of age)
- Requirement of long term enteral tube feeding (> to 12 months) and are due for a change of their initial or prior replacement bolus Percutaneous Endoscopic Gastrostomy (PEG) tube.
- Ability to consent for the procedure and study.
- Subjects must be able to communicate in english via telephone and understand the assessment checklists.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Capsule Dome G-TubeFeeding replacement tubes with two different FDA approved devices in forty subjects | Device | Capsule Dome G-Tube |
| Balloon Bolus feeding tubeFeeding replacement tubes with two different FDA approved devices in forty subjects | Device | Balloon Bolus feeding tube |
Primary outcome
Comparison of PEG tube device longevity
Time frame: Up to twelve months
Time (metric is looking at Q3 month follow-up for one year)
1 secondary outcome
Measure the cost difference of two PEG tube devices
Time frame: Up to twelve months
Results and safety
The study was stopped early (reason given: Inability to recruit study participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Long Term Enteral Tube Feeding
Recruiting
Plant-Protein Dominant Tube Feed Study
Enteral Nutrition (Food for Special Medical Purposes), Enteral Feeds
Enrolling by invitationObservational study
Enteral Nutrition Education Provided Using the Pecha Kucha Method
Training, Intensive Care (ICU)
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. This study is not recruiting at the moment.
Jeffery R Groce, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capsule Dome G-Tube and Balloon Bolus feeding tube in people with Long Term Enteral Tube Feeding, run by Ohio State University at 1 site in United States.
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 13 inclusion and 0 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: stopped early, as of the sponsor's last update on 2 Mar 2026. 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 United States. 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?
The study was stopped early (reason given: Inability to recruit study participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of PEG tube device longevity (time frame: Up to twelve months). 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 2 Mar 2026.