Gastroenterology SurgeryTube AnchorNCT07115134
Efficacy of a Novel Prototype Gastrostomy Tube Anchor Dressing
A study testing Bearables Gastrostomy Tube Dressing in people with Gastroenterology Surgery and Tube Feeding, run by Children's National Research Institute at 1 site in United States.
Trial summary
This is a single-center prospective study evaluating the efficacy of a prototype gastrostomy anchor dressing for use with button gastrostomy tubes. The anchor dressing has been previously evaluated for usability by parents, patients, and nurses. Read more about this study
- Who is it for?
- Ages 7 to 21 years
- Conditions the study is for
- Gastroenterology Surgery, Tube Feeding
- What is being tested?
- Bearables Gastrostomy Tube Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2024to 18 Dec 2027
- Phase
- Interventional
- 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 7 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients who are undergoing gastrostomy tube placement or are within five days post-operatively of gastrostomy tube placement.
Who cannot join
- 1. Patients with a skin condition that limits the placement of the dressing, this will be confirmed with the clinical team
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20010
About this study
This is a single-center prospective study evaluating the efficacy of a prototype gastrostomy anchor dressing for use with button gastrostomy tubes. The anchor dressing has been previously evaluated for usability by parents, patients, and nurses. This study compares several outcomes related to complications from gastrostomy tube placement using a prospective cohort of patients and a retrospective analysis of complications associated with gastrostomy tubes. Prospective patients will initially be monitored until they have completed their last dressing change or for a maximum of 50 days. They will then complete their final survey. Their charts will be reviewed for up to one year from their initial gastrostomy placement. The study's primary objective is to determine if the novel gastrostomy tube anchor dressing reduces rates of gastrostomy tube dislodgement and ED/clinic visits for gastrostomy tube complications.
- Conditions
- Gastroenterology Surgery, Tube Feeding
- Being tested
- Bearables Gastrostomy Tube Dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bearables Gastrostomy Tube DressingDevice
The gastrostomy tube dressing in its current design is composed of two parts, both of which are external to the patient: one part is rigid and holds the gastrostomy at a fixed position, this is a 3D printed design that is produced here. The second part is a 3" x 3" flexible, cushioned, biocompatible adhesive bandage designed to fit around the skin opening (Silicone Foam Dressing, NH NeuHeils, USA). The design is subject to minor changes including the number of parts and location with the structure of the padding and securement but will continue to be designed with comfort as a priority. After assembly, the device is packaged (sterilization pouches, Plastcareusa, USA), sealed, and sanitized using UV light prior to patient use.
| Study group | Role | What they receive |
|---|---|---|
| Bearables Gastrostomy Tube Dressing Prototype | Experimental | Not described Receives: Device: Bearables Gastrostomy Tube Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates Gastrostomy Tube Dislodgement Before and After Dressing Placement
Current rates of gastrostomy tube complications and dislodgement will be evaluated with our retrospective review, then compared to rates of complications and dislodgement after our novel dressing placement. This was chosen as complications after gastrostomy tube placement are high, and we believe that our dressing will lower them.
Measured: Up to one year
Gastrostomy tube complications
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start24 Sep 2024
- Primary completion18 Dec 2027 (estimated)
- Study completion18 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroenterology SurgeryStudies of the same condition, open and under way.
- More trials run by Children's National Research InstituteThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115134
- Sponsor's protocol ID
- STUDY00001158
- Acronym
- Tube Anchor
- Status last verified
- Aug 2025
- First submitted
- 28 Jul 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Novel Prototype Gastrostomy Tube Anchor Dressing
- ClinicalTrials.gov ID
- NCT07115134
- Acronym / sponsor ID
- Tube Anchor / STUDY00001158
- Conditions
- Gastroenterology Surgery, Tube Feeding
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- 18 Dec 2027 (estimated)
- Study completion
- 18 Dec 2027 (estimated)
- First posted
- 11 Aug 2025 (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 is a single-center prospective study evaluating the efficacy of a prototype gastrostomy anchor dressing for use with button gastrostomy tubes. The anchor dressing has been previously evaluated for usability by parents, patients, and nurses. This study compares several outcomes related to complications from gastrostomy tube placement using a prospective cohort of patients and a retrospective analysis of complications associated with gastrostomy tubes. Prospective patients will initially be monitored until they have completed their last dressing change or for a maximum of 50 days. They will then complete their final survey. Their charts will be reviewed for up to one year from their initial gastrostomy placement. The study's primary objective is to determine if the novel gastrostomy tube anchor dressing reduces rates of gastrostomy tube dislodgement and ED/clinic visits for gastrostomy tube complications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bearables Gastrostomy Tube Dressing Prototype | Experimental | Device: Bearables Gastrostomy Tube Dressing |
Who may qualify
- Ages
- 7 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients who are undergoing gastrostomy tube placement or are within five days post-operatively of gastrostomy tube placement.
Key exclusion criteria (1 listed)
- 1. Patients with a skin condition that limits the placement of the dressing, this will be confirmed with the clinical team
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 |
|---|---|---|
| Bearables Gastrostomy Tube DressingThe gastrostomy tube dressing in its current design is composed of two parts, both of which are external to the patient: one part is rigid and holds the gastrostomy at a fixed position, this is a 3D printed design that is produced here. The second part is a 3" x 3" flexible, cushioned, biocompatible adhesive bandage designed to fit around the skin opening (Silicone Foam Dressing, NH NeuHeils, USA). The design is subject to minor changes including the number of parts and location with the structure of the padding and securement but will continue to be designed with comfort as a priority. After assembly, the device is packaged (sterilization pouches, Plastcareusa, USA), sealed, and sanitized using UV light prior to patient use. | Device | Bearables Gastrostomy Tube Dressing Prototype |
Primary outcome
Rates Gastrostomy Tube Dislodgement Before and After Dressing Placement
Time frame: Up to one year
Current rates of gastrostomy tube complications and dislodgement will be evaluated with our retrospective review, then compared to rates of complications and dislodgement after our novel dressing placement. This was chosen as complications after gastrostomy tube placement are high, and we believe that our dressing will lower them.
Gastrostomy tube complications
Time frame: Up to one 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 11 Aug 2025.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bearables Gastrostomy Tube Dressing in people with Gastroenterology Surgery and Tube Feeding, run by Children's National Research Institute 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 1 inclusion and 1 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 11 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 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?
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 Anthony Sandler (202-476-5760, asandler@childrensnational.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates Gastrostomy Tube Dislodgement Before and After Dressing Placement (time frame: Up to one year). 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 11 Aug 2025.