Morbid ObesityNCT05486325
Pilot Study of the Endolumik Gastric Calibration Tube for Bariatric Surgery
A study testing Endolumik Gastric Calibration Tube (EGCT) in people with Morbid Obesity, run by Endolumik, Inc at 1 site in United States.
Trial summary
The pilot study will be a First In Human Clinical Trial to evaluate the Endolumik Gastric Calibration Tube and associated methods in a human clinical cohort of 20-30 bariatric patients at two high-volume bariatric programs. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Endolumik Gastric Calibration Tube (EGCT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2022to Dec 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking
- Adults (between age of 18 and 65 years old)
- Have body mass index (BMI) between 35 and 65.99 kg/m2
- Male or female bariatric patients undergoing bariatric surgery at one of the two sites included in the protocol.
Who cannot join
- Nonbariatric patients
- Patients who have conditions that preclude a sleeve gastrectomy or gastric bypass operation
- Patients with esophageal stricture
- Patients with esophageal varices
- Patients with a Zenker's diverticulum
- Patients aged 66 and older
Show all 10Show fewer
- Patients with a BMI of 66 kg/m2 or greater
- Pregnant Women
- Lactating Women
- Other vulnerable patient populations: pregnant and lactating women, prisoners, cognitively impaired and critically ill subjects.
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University
Morgantown, West Virginia, 26505
Katie Schneller, 304-293-3993, wvusponsoredprograms@mail.wvu.edu
Lawrence Tabone, Dr., 3042931728, letabone@hsc.wvu.edu
About this study
The pilot study will be a First In Human Clinical Trial to evaluate the Endolumik Gastric Calibration Tube and associated methods in a human clinical cohort of 20-30 bariatric patients at two high-volume bariatric programs. During this clinical study, the single-use, disposable Endolumik Gastric Calibration Tube will be used during twenty sleeve gastrectomy operations and gastric bypass operations.
Read the detailed description
Endolumik Inc. has developed a fluorescence-guided calibration device, the Endolumik Gastric Calibration Tube, to improve visualization during bariatric operations. The present pilot study will be a First In Human Clinical Trial to evaluate the Endolumik Gastric Calibration Tube and associated methods in a human clinical cohort of 20-30 bariatric patients at two high-volume bariatric programs. During this clinical study, the single-use, disposable Endolumik Gastric Calibration Tube will be used during twenty sleeve gastrectomy operations and gastric bypass operations. The goal of the present study is to confirm that the Endolumik Gastric Calibration Tube performs similar to predicate devices currently on the market, as well as to get end-user feedback prior to submitting a 510(k) application to the U.S. Food and Drug Administration (FDA).
In this multicenter trial, both study sites are certified as Bariatric Centers of Excellence through the American Society of Metabolic and Bariatric Surgery. The first clinical site is Ruby Memorial Hospital, part of West Virginia University; the second clinical site is Durham Regional Hospital, part of Duke University.
To date, using funding from a West Virginia Clinical \& Translational Science Institute Launch Pilot Grant, our team has validated the device and associated methods of fluorescence-guided sleeve gastrectomy and fluorescence-guided gastric bypass in ex-vivo and in-vivo porcine models, as well as human cadaveric tissue models. Based on FDA criteria, this investigational device meets the definition of a Non-Significant Risk (NSR) device; the risk classification document is included with submission materials.
The investigational device provided will have met design controls per FDA code of federal regulation (CFR): 21 CFR 820.30. Endolumik Inc. will serve as the industry sponsor for this study and will donate the devices being used for the protocol to the two participating study sites. Development of the technology in this research is supported by the West Virginia University Department of Surgery.
- Conditions
- Morbid Obesity
- Being tested
- Endolumik Gastric Calibration Tube (EGCT)
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endolumik Gastric Calibration Tube (EGCT)Device
Up to twenty participants will undergo laparoscopic or robotic sleeve gastrectomy using the EGCT. This operation will take approximately 60 minutes.
The portions of the sleeve gastrectomy operation where the EGCT will be used include:
- To evacuate gastric contents
- During construction of the gastric sleeve
- To perform the leak test of the gastric sleeve Up to ten participants will undergo laparoscopic gastric bypass using the EGCT. This operation will take approximately 120 minutes.
The portions of the gastric bypass operation where the EGCT will be used include:
- To evacuate gastric contents
- During construction of the gastric pouch
- To calibrate closure of the gastrojejunal anastomosis
- To perform a leak test of the gastrojejunal anastomosis In both procedures, The amount of time the EGCT will be inside the patient is approximately 20 minutes. The device is removed prior to the conclusion of the operation, while the patient is under anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Bariatric Surgery | Experimental | Up to twenty participants meeting inclusion criteria will undergo laparoscopic or robotic sleeve gastrectomy using the Endolumik Gastric Calibration Tube instead of the standard bougie calibration tube. Up to ten participants meeting inclusion criteria will undergo laparoscopic gastric bypass using the Endolumik Gastric Calibration Tube instead of the standard calibration tube. Receives: Device: Endolumik Gastric Calibration Tube (EGCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative adverse events
Adverse events occurring during surgical treatment
Measured: During surgical treatment
Operative time
Duration of surgical treatment
Measured: During surgical treatment
30-day morbidity
any 30-day Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) Occurrences
Measured: 30 days post surgical treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study startAug 2022 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The sample size (n) will be 20-30 Bariatric patients. Twenty participants will undergo laparoscopic or robotic sleeve gastrectomy using the Endolumik Gastric Calibration Tube instead of the standard bougie calibration tube. Ten participants will undergo laparoscopic gastric bypass using the Endolumik Gastric Calibration Tube instead of the standard calibration tube. The current pilot protocol is a qualitative, not quantitative, study design, thus no power calculation is indicated. The goal of the present pilot study is to serve as the First In Human trial and confirm that the Endolumik Gastric Calibration Tube performs similar to predicate devices currently on the market, as well as to get end-user feedback prior to 510(k) application to the FDA. The sample size was chosen because 20 to 30 uses will allow the development team to appropriately evaluate device performance.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endolumik, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- West Virginia University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486325
- Sponsor's protocol ID
- Pro00058006
- Status last verified
- Aug 2022
- First submitted
- 1 Aug 2022
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
English WJ, DeMaria EJ, Brethauer SA, Mattar SG, Rosenthal RJ, Morton JM. American Society for Metabolic and Bariatric Surgery estimation of metabolic and bariatric procedures performed in the United States in 2016. Surg Obes Relat Dis. 2018 Mar;14(3):259-263. doi: 10.1016/j.soard.2017.12.013. Epub 2017 Dec 16.
PubMed 29370995Mahawar KK. Bougie-Related Oesophageal Injury with Bariatric Surgery: An Unrecognised Problem. Obes Surg. 2016 Aug;26(8):1935-6. doi: 10.1007/s11695-016-2213-1. No abstract available.
PubMed 27129804Lovece A, Rouvelas I, Hayami M, Lindblad M, Tsekrekos A. Cervical esophageal perforation caused by the use of bougie during laparoscopic sleeve gastrectomy: a case report and review of the literature. BMC Surg. 2020 Jan 10;20(1):9. doi: 10.1186/s12893-020-0679-1.
PubMed 31924187
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Endolumik Gastric Calibration Tube for Bariatric Surgery
- ClinicalTrials.gov ID
- NCT05486325
- Acronym / sponsor ID
- Pro00058006
- Conditions
- Morbid Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Endolumik, IncIndustry (pharma, biotech, devices)
- Collaborators
- West Virginia University
- Study start
- Aug 2022 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 3 Aug 2022 (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.
The pilot study will be a First In Human Clinical Trial to evaluate the Endolumik Gastric Calibration Tube and associated methods in a human clinical cohort of 20-30 bariatric patients at two high-volume bariatric programs. During this clinical study, the single-use, disposable Endolumik Gastric Calibration Tube will be used during twenty sleeve gastrectomy operations and gastric bypass operations.
Detailed description
Endolumik Inc. has developed a fluorescence-guided calibration device, the Endolumik Gastric Calibration Tube, to improve visualization during bariatric operations. The present pilot study will be a First In Human Clinical Trial to evaluate the Endolumik Gastric Calibration Tube and associated methods in a human clinical cohort of 20-30 bariatric patients at two high-volume bariatric programs. During this clinical study, the single-use, disposable Endolumik Gastric Calibration Tube will be used during twenty sleeve gastrectomy operations and gastric bypass operations. The goal of the present study is to confirm that the Endolumik Gastric Calibration Tube performs similar to predicate devices currently on the market, as well as to get end-user feedback prior to submitting a 510(k) application to the U.S. Food and Drug Administration (FDA).
In this multicenter trial, both study sites are certified as Bariatric Centers of Excellence through the American Society of Metabolic and Bariatric Surgery. The first clinical site is Ruby Memorial Hospital, part of West Virginia University; the second clinical site is Durham Regional Hospital, part of Duke University.
To date, using funding from a West Virginia Clinical \& Translational Science Institute Launch Pilot Grant, our team has validated the device and associated methods of fluorescence-guided sleeve gastrectomy and fluorescence-guided gastric bypass in ex-vivo and in-vivo porcine models, as well as human cadaveric tissue models. Based on FDA criteria, this investigational device meets the definition of a Non-Significant Risk (NSR) device; the risk classification document is included with submission materials.
The investigational device provided will have met design controls per FDA code of federal regulation (CFR): 21 CFR 820.30. Endolumik Inc. will serve as the industry sponsor for this study and will donate the devices being used for the protocol to the two participating study sites. Development of the technology in this research is supported by the West Virginia University Department of Surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The sample size (n) will be 20-30 Bariatric patients. Twenty participants will undergo laparoscopic or robotic sleeve gastrectomy using the Endolumik Gastric Calibration Tube instead of the standard bougie calibration tube. Ten participants will undergo laparoscopic gastric bypass using the Endolumik Gastric Calibration Tube instead of the standard calibration tube. The current pilot protocol is a qualitative, not quantitative, study design, thus no power calculation is indicated. The goal of the present pilot study is to serve as the First In Human trial and confirm that the Endolumik Gastric Calibration Tube performs similar to predicate devices currently on the market, as well as to get end-user feedback prior to 510(k) application to the FDA. The sample size was chosen because 20 to 30 uses will allow the development team to appropriately evaluate device performance.
| Arm | Type | Receives |
|---|---|---|
| Bariatric Surgery | Experimental | Device: Endolumik Gastric Calibration Tube (EGCT)Up to twenty participants meeting inclusion criteria will undergo laparoscopic or robotic sleeve gastrectomy using the Endolumik Gastric Calibration Tube instead of the standard bougie calibration tube. Up to ten participants meeting inclusion criteria will undergo laparoscopic gastric bypass using the Endolumik Gastric Calibration Tube instead of the standard calibration tube. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English speaking
- Adults (between age of 18 and 65 years old)
- Have body mass index (BMI) between 35 and 65.99 kg/m2
- Male or female bariatric patients undergoing bariatric surgery at one of the two sites included in the protocol.
Key exclusion criteria (10 listed)
- Nonbariatric patients
- Patients who have conditions that preclude a sleeve gastrectomy or gastric bypass operation
- Patients with esophageal stricture
- Patients with esophageal varices
- Patients with a Zenker's diverticulum
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 |
|---|---|---|
| Endolumik Gastric Calibration Tube (EGCT)Up to twenty participants will undergo laparoscopic or robotic sleeve gastrectomy using the EGCT. This operation will take approximately 60 minutes. The portions of the sleeve gastrectomy operation where the EGCT will be used include: * To evacuate gastric contents * During construction of the gastric sleeve * To perform the leak test of the gastric sleeve Up to ten participants will undergo laparoscopic gastric bypass using the EGCT. This operation will take approximately 120 minutes. The portions of the gastric bypass operation where the EGCT will be used include: * To evacuate gastric contents * During construction of the gastric pouch * To calibrate closure of the gastrojejunal anastomosis * To perform a leak test of the gastrojejunal anastomosis In both procedures, The amount of time the EGCT will be inside the patient is approximately 20 minutes. The device is removed prior to the conclusion of the operation, while the patient is under anesthesia. | Device | Bariatric Surgery |
Primary outcome
Intraoperative adverse events
Time frame: During surgical treatment
Adverse events occurring during surgical treatment
Operative time
Time frame: During surgical treatment
Duration of surgical treatment
30-day morbidity
Time frame: 30 days post surgical treatment
any 30-day Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) Occurrences
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Background: PubMed 29370995English WJ, DeMaria EJ, Brethauer SA, Mattar SG, Rosenthal RJ, Morton JM. American Society for Metabolic and Bariatric Surgery estimation of metabolic and bariatric procedures performed in the United States in 2016. Surg Obes Relat Dis. 2018 Mar;14(3):259-263. doi: 10.1016/j.soard.2017.12.013. Epub 2017 Dec 16.
- Background: PubMed 27129804Mahawar KK. Bougie-Related Oesophageal Injury with Bariatric Surgery: An Unrecognised Problem. Obes Surg. 2016 Aug;26(8):1935-6. doi: 10.1007/s11695-016-2213-1. No abstract available.
- Background: PubMed 31924187Lovece A, Rouvelas I, Hayami M, Lindblad M, Tsekrekos A. Cervical esophageal perforation caused by the use of bougie during laparoscopic sleeve gastrectomy: a case report and review of the literature. BMC Surg. 2020 Jan 10;20(1):9. doi: 10.1186/s12893-020-0679-1.
- Morbid Obesity DataLink provided by the sponsor.
- Morbid Obesity DataLink provided by the sponsor.
- Bariatric Surgery DataLink provided by the sponsor.
- Fluorescence Guided SurgeryLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endolumik Gastric Calibration Tube (EGCT) in people with Morbid Obesity, run by Endolumik, Inc 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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 3 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mara McFadden (5104684426, mcfadden@endolumik.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative adverse events (time frame: During surgical treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05486325, which also lists 3 linked publications.
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 3 Aug 2022.