Malignant Small Bowel ObstructionNCT04375462
AspireAssist for Palliative Venting Gastrostomy in Malignant Bowel Obstruction Patients
A study testing AspireAssist device, Standard decompressive PEG tube and gastric outlet obstruction scoring system (GOOSS) questionnaire in people with Malignant Small Bowel Obstruction and Malignant Gastric Outlet Obstruction, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
Individuals with cancer causing an intestinal or stomach obstruction often require gastric drainage to prevent symptoms of nausea, vomiting, and to prevent aspiration. This is often achieved by a nasogastric (NG) tube, although prolonged NG tube use can lead to unwanted side effects like ulcers, bleeding, and they are… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Small Bowel Obstruction, Malignant Gastric Outlet Obstruction
- What is being tested?
- AspireAssist device, Standard decompressive PEG tube and gastric outlet obstruction scoring system (GOOSS) questionnaire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 1 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Malignant (cancer of any type) gastric or small bowel obstruction referred to surgery for placement of a venting gastrostomy tube for gastric decompression
- Able to demonstrate the ability to use the AspireAssist prior to placement
Who cannot join
- Those who are immobile and unable to at least sit up in bed to vent the gastrostomy tube.
- Undergoing placement of a gastrostomy tube for any other indication other than malignant small bowel or gastric outlet obstruction.
- Absolute contraindications to gastrostomy tube placement, such as occluding oral or esophageal tumors
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Individuals with cancer causing an intestinal or stomach obstruction often require gastric drainage to prevent symptoms of nausea, vomiting, and to prevent aspiration. This is often achieved by a nasogastric (NG) tube, although prolonged NG tube use can lead to unwanted side effects like ulcers, bleeding, and they are generally uncomfortable. Gastric drainage through the use of a percutaneously placed endoscopic gastrostomy (PEG) tube has been used in people with cancer since the 1980s. This allows relief of symptoms of malignant bowel obstruction though venting of stomach contents. Decompressive PEG tubes are routinely used in individuals with malignant obstruction, although these tubes tend to get clogged from food blocking the tube.
The AspireAssist is a weight loss device that allows participants to remove a large amount of the food in their stomachs after each meal to help them to lose weight via an aspiration device attached to the abdominal portion of the tube which allows instillation of water into the stomach, followed by aspiration of the gastric contents into a receptacle or the toilet. The device is placed endoscopically in an identical fashion to a standard PEG tube. Although most commonly used for weight loss, the device is FDA cleared to be used as a venting tube as well.
The purpose of this study is to determine if the AspireAssist provides an improved quality of life when compared with a standard venting gastrostomy tube for participants with malignant bowel obstructions.
Read the detailed description
This multicentered study will enroll participants into two cohorts of (study and control groups). The study group will undergo AspireAssist gastrostomy tube placement and the control group will undergo standard decompressive percutaneous gastrostomy tube placement. Individuals who present for venting gastrostomy placement in clinic or as consults will be approached for inclusion. Gastrostomy tubes will be placed 1-2 days after enrollment to allow for thoroughly consideration of inclusion by potential participants. Gastrostomy tube placement will be completed endoscopically in the standard "pull" method in both the AspireAssist and PEG groups. Questionnaires will be completed at 7 and 30 days.
The primary objective of this study is to evaluate to compare healthcare utilization, including major and minor tube related complications between the two groups. Secondary objectives of this study are to compare changes in the ability to eat and drink after placement of the gastrostomy tube and to evaluate changes in quality of life before and after gastrostomy tube placement.
- Being tested
- AspireAssist device, Standard decompressive PEG tube, gastric outlet obstruction scoring system (GOOSS) questionnaire, Modified Gastroparesis Cardinal Symptom Index (GCSI) questionnaire, Patient satisfaction and ease of use survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspireAssist deviceDevice
Allows for aspiration of gastric contents into a receptacle or the toilet to prevent symptoms of nausea, vomiting, and to prevent aspiration.
Device is placed endoscopically in an identical fashion to a standard PEG tube G 1-2 days after enrollment
Standard decompressive PEG tubeDevice
Allows for gastric drainage to prevent symptoms of nausea, vomiting, and to prevent aspiration.
Device is placed endoscopically 1-2 days after enrollment
gastric outlet obstruction scoring system (GOOSS) questionnaireOther
Gastric outlet obstruction scoring system (GOOSS) questionnaire
Both groups will receive the questionnaires via a phone call
Modified Gastroparesis Cardinal Symptom Index (GCSI) questionnaireOther
Modified Gastroparesis Cardinal Symptom Index (GCSI) questionnaire
Both groups will receive the questionnaires via a phone call
Patient satisfaction and ease of use surveyOther
Patient satisfaction and ease of use survey
Both groups will receive the questionnaires via a phone call
| Study group | Role | What they receive |
|---|---|---|
| AspireAssist | Experimental | Gastrostomy tubes will be placed 1-2 days after enrollment. Questionnaires will be completed at 7 and 30 days, and the AspireAssist group will have a clinic visit at 7 days to have the skin-port placed.
All participants will be placed on a diet consisting of liquids and soft foods to prevent clogging of the gastrostomy tube Receives: Device: AspireAssist device; Other: gastric outlet obstruction scoring system (GOOSS) questionnaire; Other: Modified Gastroparesis Cardinal Symptom Index (GCSI) questionnaire; Other: Patient satisfaction and ease of use survey |
| Standard PEG | Active comparator | Gastrostomy tubes will be placed 1-2 days after enrollment. Questionnaires will be completed at 7 and 30 days All participants will be placed on a diet consisting of liquids and soft foods to prevent clogging of the gastrostomy tube Receives: Device: Standard decompressive PEG tube; Other: gastric outlet obstruction scoring system (GOOSS) questionnaire; Other: Modified Gastroparesis Cardinal Symptom Index (GCSI) questionnaire; Other: Patient satisfaction and ease of use survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of tube related complications per day
Number of tube related complications per day, including tube clogging, skin infection, dislodgement, etc.
Measured: at 30 days
Patient satisfaction and ease of use survey scores
Patient satisfaction and ease of use survey, with scores ranging from 0-15 with lower scores corresponding to higher satisfaction with the tube
Measured: At baseline
Patient satisfaction and ease of use survey scores
Patient satisfaction and ease of use survey, with scores ranging from 0-15 with lower scores corresponding to higher satisfaction with the tube
Measured: At 7 days from the date of tube placement
Patient satisfaction and ease of use survey scores
Patient satisfaction and ease of use survey, with scores ranging from 0-15 with lower scores corresponding to higher satisfaction with the tube
Measured: At 30 days from the date of tube placement
Quality of life as measured by Edmonton Symptom Assessment System (ESAS)
Quality of life as measured by Edmonton Symptom Assessment System (ESAS), with scores ranging from 0-100 with higher scores corresponding to worse outcomes
Measured: At baseline
Quality of life as measured by Edmonton Symptom Assessment System (ESAS)
Quality of life as measured by ESAS, with scores ranging from 0-100 with higher scores corresponding to worse outcomes
Measured: At 7 days from the date of tube placement
Quality of life as measured by Edmonton Symptom Assessment System (ESAS)
Quality of life as measured by ESAS, with scores ranging from 0-100 with higher scores corresponding to worse outcomes
Measured: At 30 days from the date of tube placement
Secondary outcomes (6)
Number of decompressions per day
Number of decompressions per day
Measured: at 30 days
Number of ED visits or readmissions for tube related problems
Number of ED visits or readmissions for tube related problems
Measured: at 30 days
Number of calls or office visits for nausea or tube related issues
Number of calls or office visits for nausea or tube related issues
Measured: at 30 days
Ability to eat/drink assessed via GOOSS
Ability to eat/drink assessed via GOOSS, with scores ranging from o to 3, with higher scores indicating higher levels of oral intake.
Pre and postoperative GOOSS scores will be compared using Wilcoxon signed rank test with a p <0.05 being considered significant
Measured: At baseline
Ability to eat/drink assessed via GOOSS
Ability to eat/drink assessed via GOOSS, with scores ranging from o to 3, with higher scores indicating higher levels of oral intake.
Pre and postoperative GOOSS scores will be compared using Wilcoxon signed rank test with a p <0.05 being considered significant
Measured: At 1 week from the date of tube placement
Ability to eat/drink assessed via GOOSS
Ability to eat/drink assessed via GOOSS, with scores ranging from o to 3, with higher scores indicating higher levels of oral intake.
Pre and postoperative GOOSS scores will be compared using Wilcoxon signed rank test with a p <0.05 being considered significant
Measured: At 30 days from the date of tube placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start1 Feb 2023 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Why it stopped: PI left CCF
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Small Bowel ObstructionStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alisan Fathalizadeh, MD, Principal investigator, Cleveland Clinic, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375462
- Sponsor's protocol ID
- CASE12219
- Status last verified
- Jan 2023
- First submitted
- 24 Mar 2020
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This is a feasibility study of 40 participants and IPD will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AspireAssist for Palliative Venting Gastrostomy in Malignant Bowel Obstruction Patients
- ClinicalTrials.gov ID
- NCT04375462
- Acronym / sponsor ID
- CASE12219
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left CCF
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 5 May 2020 (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.
Individuals with cancer causing an intestinal or stomach obstruction often require gastric drainage to prevent symptoms of nausea, vomiting, and to prevent aspiration. This is often achieved by a nasogastric (NG) tube, although prolonged NG tube use can lead to unwanted side effects like ulcers, bleeding, and they are generally uncomfortable. Gastric drainage through the use of a percutaneously placed endoscopic gastrostomy (PEG) tube has been used in people with cancer since the 1980s. This allows relief of symptoms of malignant bowel obstruction though venting of stomach contents. Decompressive PEG tubes are routinely used in individuals with malignant obstruction, although these tubes tend to get clogged from food blocking the tube.
The AspireAssist is a weight loss device that allows participants to remove a large amount of the food in their stomachs after each meal to help them to lose weight via an aspiration device attached to the abdominal portion of the tube which allows instillation of water into the stomach, followed by aspiration of the gastric contents into a receptacle or the toilet. The device is placed endoscopically in an identical fashion to a standard PEG tube. Although most commonly used for weight loss, the device is FDA cleared to be used as a venting tube as well.
The purpose of this study is to determine if the AspireAssist provides an improved quality of life when compared with a standard venting gastrostomy tube for participants with malignant bowel obstructions.
Detailed description
This multicentered study will enroll participants into two cohorts of (study and control groups). The study group will undergo AspireAssist gastrostomy tube placement and the control group will undergo standard decompressive percutaneous gastrostomy tube placement. Individuals who present for venting gastrostomy placement in clinic or as consults will be approached for inclusion. Gastrostomy tubes will be placed 1-2 days after enrollment to allow for thoroughly consideration of inclusion by potential participants. Gastrostomy tube placement will be completed endoscopically in the standard "pull" method in both the AspireAssist and PEG groups. Questionnaires will be completed at 7 and 30 days.
The primary objective of this study is to evaluate to compare healthcare utilization, including major and minor tube related complications between the two groups. Secondary objectives of this study are to compare changes in the ability to eat and drink after placement of the gastrostomy tube and to evaluate changes in quality of life before and after gastrostomy tube placement.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AspireAssist | Experimental | Device: AspireAssist device, Other: gastric outlet obstruction scoring system (GOOSS) questionnaire, Other: Modified Gastroparesis Cardinal Symptom Index (GCSI) questionnaire, Other: Patient satisfaction and ease of use surveyGastrostomy tubes will be placed 1-2 days after enrollment. Questionnaires will be completed at 7 and 30 days, and the AspireAssist group will have a clinic visit at 7 days to have the skin-port placed. All participants will be placed on a diet consisting of liquids and soft foods to prevent clogging of the gastrostomy tube |
| Standard PEG | Active comparator | Device: Standard decompressive PEG tube, Other: gastric outlet obstruction scoring system (GOOSS) questionnaire, Other: Modified Gastroparesis Cardinal Symptom Index (GCSI) questionnaire, Other: Patient satisfaction and ease of use surveyGastrostomy tubes will be placed 1-2 days after enrollment. Questionnaires will be completed at 7 and 30 days All participants will be placed on a diet consisting of liquids and soft foods to prevent clogging of the gastrostomy tube |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Malignant (cancer of any type) gastric or small bowel obstruction referred to surgery for placement of a venting gastrostomy tube for gastric decompression
- Able to demonstrate the ability to use the AspireAssist prior to placement
Key exclusion criteria (3 listed)
- Those who are immobile and unable to at least sit up in bed to vent the gastrostomy tube.
- Undergoing placement of a gastrostomy tube for any other indication other than malignant small bowel or gastric outlet obstruction.
- Absolute contraindications to gastrostomy tube placement, such as occluding oral or esophageal tumors
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 |
|---|---|---|
| AspireAssist deviceAllows for aspiration of gastric contents into a receptacle or the toilet to prevent symptoms of nausea, vomiting, and to prevent aspiration. Device is placed endoscopically in an identical fashion to a standard PEG tube G 1-2 days after enrollment | Device | AspireAssist |
| Standard decompressive PEG tubeAllows for gastric drainage to prevent symptoms of nausea, vomiting, and to prevent aspiration. Device is placed endoscopically 1-2 days after enrollment | Device | Standard PEG |
| gastric outlet obstruction scoring system (GOOSS) questionnaireGastric outlet obstruction scoring system (GOOSS) questionnaire Both groups will receive the questionnaires via a phone call | Other | AspireAssist, Standard PEG |
| Modified Gastroparesis Cardinal Symptom Index (GCSI) questionnaireModified Gastroparesis Cardinal Symptom Index (GCSI) questionnaire Both groups will receive the questionnaires via a phone call | Other | AspireAssist, Standard PEG |
| Patient satisfaction and ease of use surveyPatient satisfaction and ease of use survey Both groups will receive the questionnaires via a phone call | Other | AspireAssist, Standard PEG |
Primary outcome
Number of tube related complications per day
Time frame: at 30 days
Number of tube related complications per day, including tube clogging, skin infection, dislodgement, etc.
Patient satisfaction and ease of use survey scores
Time frame: At baseline
Patient satisfaction and ease of use survey, with scores ranging from 0-15 with lower scores corresponding to higher satisfaction with the tube
Patient satisfaction and ease of use survey scores
Time frame: At 7 days from the date of tube placement
Patient satisfaction and ease of use survey, with scores ranging from 0-15 with lower scores corresponding to higher satisfaction with the tube
Patient satisfaction and ease of use survey scores
Time frame: At 30 days from the date of tube placement
Patient satisfaction and ease of use survey, with scores ranging from 0-15 with lower scores corresponding to higher satisfaction with the tube
Quality of life as measured by Edmonton Symptom Assessment System (ESAS)
Time frame: At baseline
Quality of life as measured by Edmonton Symptom Assessment System (ESAS), with scores ranging from 0-100 with higher scores corresponding to worse outcomes
Quality of life as measured by Edmonton Symptom Assessment System (ESAS)
Time frame: At 7 days from the date of tube placement
Quality of life as measured by ESAS, with scores ranging from 0-100 with higher scores corresponding to worse outcomes
Quality of life as measured by Edmonton Symptom Assessment System (ESAS)
Time frame: At 30 days from the date of tube placement
Quality of life as measured by ESAS, with scores ranging from 0-100 with higher scores corresponding to worse outcomes
6 secondary outcomes
Number of decompressions per day
Time frame: at 30 days
Number of ED visits or readmissions for tube related problems
Time frame: at 30 days
Number of calls or office visits for nausea or tube related issues
Time frame: at 30 days
Ability to eat/drink assessed via GOOSS
Time frame: At baseline
Ability to eat/drink assessed via GOOSS
Time frame: At 1 week from the date of tube placement
Ability to eat/drink assessed via GOOSS
Time frame: At 30 days from the date of tube placement
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Individual participant dataSharing planned: No. This is a feasibility study of 40 participants and IPD will not be shared
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.
Alisan Fathalizadeh, MD principal investigator
Cleveland Clinic, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AspireAssist device, Standard decompressive PEG tube and gastric outlet obstruction scoring system (GOOSS) questionnaire in people with Malignant Small Bowel Obstruction and Malignant Gastric Outlet Obstruction, run by Case Comprehensive Cancer Center 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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 31 Jan 2023. 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 withdrawn before enrolling participants, so there are no results.
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?
Number of tube related complications per day (time frame: at 30 days). The study lists 7 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 31 Jan 2023.